49 results on '"Hengameh H. Raissy"'
Search Results
2. Considerations for Care: Management of Asthma in the Child with Sickle Cell Disease
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Hengameh H. Raissy and Kathryn V. Blake
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Pulmonary and Respiratory Medicine ,Pediatrics ,medicine.medical_specialty ,education.field_of_study ,Asthma exacerbations ,business.industry ,Population ,Disease ,medicine.disease ,Pulmonary function testing ,Prolonged QTc ,Panel report ,Pediatrics, Perinatology and Child Health ,Immunology and Allergy ,Medicine ,Treatment decision making ,business ,education ,Asthma - Abstract
Asthma is difficult to diagnose in the child with sickle cell disease because symptoms and pulmonary function abnormalities are similar to the spectrum of pulmonary manifestations in sickle cell disease. There are no published reports of controlled trials of asthma medications in children with sickle cell disease. Thus, treatment decisions should be guided by the Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf). However, issues specific to children with sickle cell disease should be considered. Initial strategies should focus on control of environmental triggers, as effectiveness on asthma outcomes is proven and the cost for implementation can be low. Use of short- and long-acting β2-agonists may prolong QTc, particularly in this population of children who already have a higher prevalence of prolonged QTc than the general population. Long-acting β2-agonist use has been associated with life-threatening asthma exacerbations with ...
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- 2022
3. Long-term safety and efficacy of tezacaftor–ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study
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Patrick A Flume, Reta Fischer Biner, Damian G Downey, Cynthia Brown, Manu Jain, Rainald Fischer, Kris De Boeck, Gregory S Sawicki, Philip Chang, Hildegarde Paz-Diaz, Jaime L Rubin, Yoojung Yang, Xingdi Hu, David J Pasta, Stefanie J Millar, Daniel Campbell, Xin Wang, Neil Ahluwalia, Caroline A Owen, Claire E Wainwright, Ronald L. Gibson, Steven M. Rowe, Noah Lechtzin, Richard C. Ahrens, Karen S. McCoy, Moira Aitken, Scott H. Donaldson, Kimberly Ann McBennett, Joseph M. Pilewski, Joanne Billings, Carlos Milla, Ronald Rubenstein, Daniel Brian Rosenbluth, Rachel Linnemann, Michael R. Powers, Christopher Fortner, Carla Anne Frederick, Theodore G. Liou, Philip Black, Janice Wang, John L. Colombo, Maria Berdella, Maria Veronica Indihar, Cynthia D. Brown, Michael Anstead, Lara Bilodeau, Leonard Sicilian, James Jerome Tolle, Kathryn Moffett, Samya Nasr, Jennifer Taylor-Cousar, Tara Lynn Barto, Nicholas Antos, John S. Rogers, Bryon Quick, Henry R. Thompson, Gregory Sawicki, Bruce Barnett, Robert L. Zanni, Thomas C. Smith, Karen D. Schultz, Claire Keating, Patrick Flume, Gregory J. Omlor, Alix Ashare, Karen Voter, Nighat Mehdi, Maria Gabriela Tupayachi Ortiz, Tonia E. Gardner, Steven R. Boas, Barbara Messore, Edith Zemanick, Raksha Jain, Michael McCarthy, Dana G. Kissner, Kapilkumar Patel, John McNamara, Julie Philley, Ariel Berlinski, Francisco J. Calimano, Terry Chin, Douglas Conrad, Cori Daines, Hengameh H. Raissy, Thomas G. Keens, Jorge E. Lascano, Bennie McWilliams, Brian Morrissey, Santiago Reyes, Subramanyam Chittivelu, Sabiha Hussain, Arvey Stone, James Wallace, Ross Klingsberg, Julie A. Biller, Stephanie Bui, Olaf Sommerburg, Elisabetta Bignamini, Mirella Collura, Alexander Moller, Donatello Salvatore, Chantal Belleguic, Lea Bentur, Ori Efrati, Eitan Kerem, Dario Prais, Esther Quintana Gallego, Peter Barry, Galit Livnat-Levanon, Jose Ramon Villa Asensi, David Stuart Armstrong, Oscar Asensio de la Cruz, Francis Gilchrist, Diana Elizabeth Tullis, Bradley Quon, Larry C. Lands, Nancy Morrison, Annick Lavoie, Barry Linnane, Okan Elidemir, Felix Ringshausen, Matthias Kappler, Helge Hebestreit, Jochen Mainz, Alexander Kiefer, Cordula Koerner-Rettberg, Doris Staab, Wolfgang Gleiber, Tacjana Pressler, Florian Stehling, Andreas Hector, Sivagurunathan Sutharsan, Lutz Naehrlich, Damian Downey, Jane Carolyn Davies, Robert Ian Ketchell, Mary Patricia Carroll, Simon Doe, Gordon MacGregor, Edward Fairbairn Nash, Nicholas Withers, Daniel Gavin Peckham, Martin James Ledson, Sonal Kansra, Timothy William Rayner Lee, Bertrand Delaisi, Gilles Rault, Jean Le Bihan, Dominique Hubert, Isabelle Fajac, Isabelle Sermet-Gaudelus, Marleen Bakker, Bert Arets, Christiane De Boeck, Raphael Chiron, Philippe Reix, Catherine Mainguy, Eva van Braeckel, Anne Malfroot, Isabelle Durieu, Nadine Desmazes Dufeu, Anne Prevotat, Renske van der Meer, Petrus Merkus, E.J.M. Weersink, Isabel Barrio Gomez-Aguero, Silvia Gartner, Amparo Sole Jover, Antonio Alvarez Fernandez, Desmond William Cox, Edward F. McKone, Barry James Plant, Hiranjan Selvadurai, Simon David Bowler, Claire Elizabeth Wainwright, Daniel Smith, Peter Gordon Middleton, John William Wilson, Sonia Volpi, Carla Colombo, Benedetta Fabrizzi, Vincenzina Lucidi, Federico Cresta, Salvatore Cucchiara, Ernst Eber, Helmut Ellemunter, Isidor Huttegger, Lena Hjelte, Christina Krantz, Marita Gilljam, and Pulmonology
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Adult ,Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Indoles ,Cystic Fibrosis ,Cystic Fibrosis Transmembrane Conductance Regulator ,Quinolones ,Aminophenols ,Cystic fibrosis ,Time ,Ivacaftor ,03 medical and health sciences ,0302 clinical medicine ,Pharmacokinetics ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Benzodioxoles ,030212 general & internal medicine ,Israel ,biology ,business.industry ,Australia ,medicine.disease ,Cystic fibrosis transmembrane conductance regulator ,Discontinuation ,Europe ,Drug Combinations ,Treatment Outcome ,Clinical research ,030228 respiratory system ,Tolerability ,Mutation ,North America ,biology.protein ,Female ,business ,medicine.drug - Abstract
Summary Background Tezacaftor–ivacaftor is an approved cystic fibrosis transmembrane conductance regulator (CFTR) modulator shown to be efficacious and generally safe and well tolerated over 8–24 weeks in phase 3 clinical studies in participants aged 12 years or older with cystic fibrosis homozygous for the Phe508del CFTR mutation (F/F; study 661-106 [EVOLVE]) or heterozygous for the Phe508del CFTR mutation and a residual function mutation (F/RF; study 661-108 [EXPAND]). Longer-term (>24 weeks) safety and efficacy of tezacaftor–ivacaftor has not been assessed in clinical studies. Here, we present results of study 661-110 (EXTEND), a 96-week open-label extension study that assessed long-term safety, tolerability, and efficacy of tezacaftor–ivacaftor in participants aged 12 years or older with cystic fibrosis who were homozygous or heterozygous for the Phe508del CFTR mutation. Methods Study 661-110 was a 96-week, phase 3, multicentre, open-label study at 170 clinical research sites in Australia, Europe, Israel, and North America. Participants were aged 12 years or older, had cystic fibrosis, were homozygous or heterozygous for Phe508del CFTR, and completed one of six parent studies of tezacaftor–ivacaftor: studies 661-103, 661-106, 661-107, 661-108, 661-109, and 661-111. Participants received oral tezacaftor 100 mg once daily and oral ivacaftor 150 mg once every 12 h for up to 96 weeks. The primary endpoint was safety and tolerability. Secondary endpoints were changes in lung function, nutritional parameters, and respiratory symptom scores; pulmonary exacerbations; and pharmacokinetic parameters. A post-hoc analysis assessed the rate of lung function decline in F/F participants who received up to 120 weeks of tezacaftor–ivacaftor in studies 661-106 (F/F) and/or 661-110 compared with a matched cohort of CFTR modulator-untreated historical F/F controls from the Cystic Fibrosis Foundation Patient Registry. Primary safety analyses were done in all participants from all six parent studies who received at least one dose of study drug during this study. This study was registered at ClinicalTrials.gov ( NCT02565914 ). Findings Between Aug 31, 2015, to May 31, 2019, 1044 participants were enrolled in study 661-110 from the six parent studies of whom 1042 participants received at least one dose of study drug and were included in the safety set. 995 (95%) participants had at least one TEAE; 22 (2%) had TEAEs leading to discontinuation; and 351 (34%) had serious TEAEs. No deaths occurred during the treatment-emergent period; after the treatment-emergent period, two deaths occurred, which were both deemed unrelated to study drug. F/F (106/110; n=459) and F/RF (108/110; n=226) participants beginning tezacaftor–ivacaftor in study 661-110 had improvements in efficacy endpoints consistent with parent studies; improvements in lung function and nutritional parameters and reductions in pulmonary exacerbations observed in the tezacaftor–ivacaftor groups in the parent studies were generally maintained in study 661-110 for an additional 96 weeks. Pharmacokinetic parameters were also similar to those in the parent studies. The annualised rate of lung function decline was 61·5% (95% CI 35·8 to 86·1) lower in tezacaftor–ivacaftor-treated F/F participants versus untreated matched historical controls. Interpretation Tezacaftor–ivacaftor was generally safe, well tolerated, and efficacious for up to 120 weeks, and the safety profile of tezacaftor–ivacaftor in study 661-110 was consistent with cystic fibrosis manifestations and with the safety profiles of the parent studies. The rate of lung function decline was significantly reduced in F/F participants, consistent with cystic fibrosis disease modification. Our results support the clinical benefit of long-term tezacaftor–ivacaftor treatment for people aged 12 years or older with cystic fibrosis with F/F or F/RF genotypes. Funding Vertex Pharmaceuticals Incorporated.
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- 2021
4. Factors Associated with Persistence of Severe Asthma from Late Adolescence to Early Adulthood
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Neema Izadi, David Baraghoshi, Douglas Curran-Everett, Robert S. Zeiger, Stanley J. Szefler, Ronina A. Covar, Paul Williams, Mary V. Lasley, Tamara Chinn, Michele Hinatsu, Clifton T. Furukawa, Leonard C. Altman, Frank S. Virant, Michael S. Kennedy, Stephen Tilles, Jonathan W. Becker, C. Warren Bierman, Dan Crawford, Thomas DuHamel, Heather Eliassen, Babi Hammond, Miranda MacLaren, Dominick A. Minotti, Chris Reagan, Gail Shapiro, Marian Sharpe, Ashley Tatum, Grace White, Timothy G. Wighton, Anne Fuhlbrigge, Anne Plunkett, Nancy Madden, Susan Anderson, Mark Boehnert, Anita Feins, Amanda Gentile, Natalia Kandror, Kelly MacAulay, Ernestina Sampong, Scott Weiss, Walter Torda, Martha Tata, Sally Babigian, Peter Barrant, Linda Benson, Jose Caicedo, Tatum Calder, Christine Darcy, Anthony DeFilippo, Cindy Dorsainvil, Julie Erickson, Phoebe Fulton, Mary Grace, Jennifer Gilbert, Dirk Greineder, Stephanie Haynes, Margaret Higham, Deborah Jakubowski, Susan Kelleher, Jay Koslof, Dana Mandel, Patricia Martin, Agnes Martinez, Jean McAuliffe, Erika Nakamoto, Paola Pacella, Paula Parks, Johanna Sagarin, Kay Seligsohn, Susan Swords, Meghan Syring, June Traylor, Melissa Van Horn, Carolyn Wells, Ann Whitman, Hartmut Grasemann, Melody Miki, Melinda Solomon, Padmaja Subbarao, Ian MacLusky, Joe Reisman, Henry Levison, Anita Hall, Yola Benedet, Susan Carpenter, Jennifer Chay, Michelle Collinson, Jane Finlayson-Kulchin, Kenneth Gore, Nina Hipolito, Noreen Holmes, Erica Hoorntje, Sharon Klassen, Joseé Quenneville, Renée Sananes, Christine Wasson, Margaret Wilson, N. Franklin Adkinson, Deborah Bull, Stephanie Philips, Peyton Eggleston, Karen Huss, Leslie Plotnick, Margaret Pulsifer, Cynthia Rand, Elizabeth Aylward, Nancy Bollers, Kathy Pessaro, Barbara Wheeler, Harold S. Nelson, Bruce Bender, Andrew Liu, D. Sundström, Melanie Phillips, Michael P. White, Melanie Gleason, Kristin Brelsford, Jessyca Bridges, Jody Ciacco, Michael Eltz, Jeryl Feeley, Michael Flynn, Tara Junk-Blanchard, Joseph Hassell, Marcia Hefner, Caroline Hendrickson, Daniel Hettleman, Charles G. Irvin, Alan Kamada, Marzena Krawiec, Gary Larsen, Sai Nimmagadda, Kendra Sandoval, Jessica Sheridan, Joseph Spahn, Gayle Spears, Trella Washington, Eric Willcutt, Kirstin Carel, Jayna Doshi, Rich Hendershot, Jeffrey Jacobs, Neal Jain, June-ku Brian Kang, Tracy Kruzick, Harvey Leo, Beth Macomber, Jonathan Malka, Chris Mjaanes, John Prpich, Lora Stewart, Ben Song, Grace Tamesis, Noah Friedman, Michael H. Mellon, Michael Schatz, Terrie Long, Travis Macaraeg, Sandra Christensen, James G. Easton, M. Feinberg, Linda L. Galbreath, Jennifer Gulczynski, Kathleen Harden, Ellen Hansen, Al Jalowayski, Elaine Jenson, Alan Lincoln, Jennie Kaufman, Shirley King, Brian Lopez, Michaela Magiari-Ene, Kathleen Mostafa, Avraham Moscona, Catherine A. Nelle, Jennifer Powers, Elsa Rodriguez, Eva Rodriguez, Karen Sandoval, Nevin W. Wilson, Hengameh H. Raissy, Aaron Jacobs, H. William Kelly, Mary Spicher, Christina Batson, Michelle Harkings, Katie McCallum, Robert Annett, Teresa Archibeque, Naim Bashir, H. Selda Bereket, Marisa Braun, Carrie Bush, Shannon C. Bush, Michael Clayton, Angel Colon-Semidey, Sara Devault, Anna Esparham, Roni Grad, David Hunt, Jeanne Larsson, Sandra McClelland, Bennie McWilliams, Elisha Montoya, Margaret Moreshead, Shirley Murphy, Barbara Ortega, David Weers, Jose Zayas, Robert C. Strunk, Leonard Bacharier, Denise Rodgers, Ellen Albers, Gregg Belle, Gordon R. Bloomberg, W. Patrick Buchanan, Mary Caesar, James M. Corry, Karen DeMuth, Marisa Dolinsky, Edwin B. Fisher, Stephen J. Gaioni, Emily Glynn, Bernadette D. Heckman, Debra Kemp, Lila Kertz, Claire Lawhon, Valerie Morgan, Cynthia Moseid, Tina Oliver-Welker, Diana Richardson, Elizabeth Ryan, Sharon Sagal, Thomas F. Smith, Susan Sylvia, Carl Turner, Deborah K. White, James Tonascia, Patricia Belt, Karen Collins, Betty Collison, John Dodge, Michele Donithan, Cathleen Ewing, Rosetta Jackson, Patrick May, Jill Meinert, Girlie Reyes, Michael Smith, Alice L. Sternberg, Mark L. Van Natta, Annette Wagoner, Laura Wilson, Robert Wise, Katherine Yates, Virginia Taggart, Lois Eggers, James Kiley, Howard Moore, Gang Zheng, Paul Albert, Suzanne Hurd, Sydney Parker, Pamela Randall, Margaret Wu, Michelle Cloutier, John Connett, Leona Cuttler, Frank Gilliland, Clarence E. Davis, Howard Eigen, David Evans, Meyer Kattan, Rogelio Menendez, F. Estelle R. Simons, Sanford Leikin, Robert Strunk, Reuben Cherniack, Thomas R. DuHamel, Curtis L. Meinert, Gail G. Shapiro, and Robert Zeiger
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Pulmonary and Respiratory Medicine ,Persistence (psychology) ,Pediatrics ,medicine.medical_specialty ,Severe asthma ,Friends ,macromolecular substances ,Critical Care and Intensive Care Medicine ,03 medical and health sciences ,Pulmonary Disease, Chronic Obstructive ,0302 clinical medicine ,Early adulthood ,medicine ,Humans ,030212 general & internal medicine ,Lung function ,Asthma ,business.industry ,musculoskeletal, neural, and ocular physiology ,Original Articles ,Late adolescence ,medicine.disease ,nervous system ,030228 respiratory system ,business - Abstract
Rationale: Asthma in children generally starts as being mild but may progress to being severe and may stay severe for unknown reasons. Objectives: To identify factors in childhood that predict the persistence of severe asthma in late adolescence and early adulthood. Methods: The CAMP (Childhood Asthma Management Program) is, to our knowledge, the largest and longest asthma trial to date; it includes 1,041 children aged 5–12 years with mild to moderate asthma. We evaluated 682 program participants with analyzable data in late adolescence (age, 17–19 yr) and early adulthood (age, 21–23 yr). Measurements and Main Results: To best capture the cases of severe asthma, a status of severe asthma was defined by using criteria from the American Thoracic Society and the National Asthma Education and Prevention Program. Logistic regression with stepwise elimination was used to analyze the clinical features, biomarkers, and lung function that are predictive of the persistence of severe asthma. In late adolescence and early adulthood, 12% and 19% of the participants had severe asthma, respectively; only 6% at both time points had severe cases. For every 5% decrease in the postbronchodilator FEV(1)/FVC ratio in childhood, the odds of the persistence of severe asthma increased by 2.36-fold (95% confidence interval [CI], 1.70–3.28; P
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- 2021
5. IDeA States Pediatric Clinical Trials Network for Underserved and Rural Communities
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Hengameh H. Raissy, Sheva Chervinskiy, Clare Nesmith, Judith L. Ross, Kelly Cowan, Paul Smith, Christi Madden, Bruce Shiramizu, Kristina Foster, Lauren Tucker, Matthew Hirschfeld, Andrew M. Atz, Kurtis R Kulbeth, J. Philip Saul, Daniel S. Hsia, Thomas H. Chun, J. Dean Jarvis, Robert D. Annett, Janice E. Sullivan, and Nathaniel Goodrich
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Rural Population ,Capacity Building ,Education, Continuing ,media_common.quotation_subject ,MEDLINE ,Medically Underserved Area ,Pediatrics ,03 medical and health sciences ,Presentation ,Special Article ,0302 clinical medicine ,030225 pediatrics ,Research Support as Topic ,Health care ,Medicine ,Humans ,media_common ,Medical education ,Clinical Trials as Topic ,business.industry ,Professional development ,Child Health ,Capacity building ,United States ,Clinical trial ,Pediatrics, Perinatology and Child Health ,Sustainability ,Portfolio ,business - Abstract
[Figure: see text] The National Institutes of Health’s Environmental Influences on Child Health Outcomes (ECHO) program aims to study high-priority and high-impact pediatric conditions. This broad-based health initiative is unique in the National Institutes of Health research portfolio and involves 2 research components: (1) a large group of established centers with pediatric cohorts combining data to support longitudinal studies (ECHO cohorts) and (2) pediatric trials program for institutions within Institutional Development Awards states, known as the ECHO Institutional Development Awards States Pediatric Clinical Trials Network (ISPCTN). In the current presentation, we provide a broad overview of the ISPCTN and, particularly, its importance in enhancing clinical trials capabilities of pediatrician scientists through the support of research infrastructure, while at the same time implementing clinical trials that inform future health care for children. The ISPCTN research mission is aligned with the health priority conditions emphasized in the ECHO program, with a commitment to bringing state-of-the-science trials to children residing in underserved and rural communities. ISPCTN site infrastructure is critical to successful trial implementation and includes research training for pediatric faculty and coordinators. Network sites exist in settings that have historically had limited National Institutes of Health funding success and lacked pediatric research infrastructure, with the initial funding directed to considerable efforts in professional development, implementation of regulatory procedures, and engagement of communities and families. The Network has made considerable headway with these objectives, opening two large research studies during its initial 18 months as well as producing findings that serve as markers of success that will optimize sustainability.
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- 2020
6. Heterogeneity of Mild to Moderate Persistent Asthma in Children: Confirmation by Latent Class Analysis and Association with 1-Year Outcomes
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David T. Mauger, Fernando Holguin, Hengameh H. Raissy, Daniel J. Jackson, Wanda Phipatanakul, Wayne J. Morgan, Jacqueline A. Pongracic, Michael D. Cabana, Theresa W. Guilbert, Avraham Beigelman, Ronina A. Covar, Robert F. Lemanske, Fernando D. Martinez, Leonard B. Bacharier, Robert S. Zeiger, Stanley J. Szefler, and Anne M. Fitzpatrick
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Adult ,medicine.medical_specialty ,Vital capacity ,Exacerbation ,Allergic sensitization ,03 medical and health sciences ,FEV1/FVC ratio ,0302 clinical medicine ,Internal medicine ,medicine ,Immunology and Allergy ,Humans ,Medical history ,030212 general & internal medicine ,Child ,Sensitization ,Asthma ,business.industry ,medicine.disease ,Latent class model ,respiratory tract diseases ,medicine.anatomical_structure ,Phenotype ,030228 respiratory system ,Latent Class Analysis ,business ,Biomarkers - Abstract
Background Compared with adults, phenotypic characterization of children with asthma is still limited and it remains difficult to predict which children with asthma are at highest risk for poor outcomes. Objective To identify latent classes in a large population of treatment-adherent children with mild to moderate asthma enrolled in clinical trials and determine whether latent class assignment predicts future lung function abnormalities and exacerbation rate. Methods Latent class analysis was performed on 2593 children with mild to moderate asthma aged 5 18 years, with 19 variables encompassing demographic characteristics, medical history, symptoms, lung function, allergic sensitization, and type 2 inflammation. Outcomes included lung function and the annualized exacerbation rate at 12 months of follow-up. Results Five latent classes were identified with differing demographic features, asthma control, sensitization, type 2 inflammatory markers, and lung function. Exacerbation rates were 1.30 ± 0.12 for class 1 (multiple sensitization with partially reversible airflow limitation), 0.90 ± 0.05 for class 2 (multiple sensitization with reversible airflow limitation), 0.87 ± 0.08 for class 3 (lesser sensitization with reversible airflow limitation), 0.87 ± 0.05 for class 4 (multiple sensitization with normal lung function), and 0.71 ± 0.06 for class 5 (lesser sensitization with normal lung function). Lung function abnormalities persisted in class 1 at 12 months. Conclusions Children with mild to moderate asthma are a heterogeneous group. Allergic sensitization and lung function may be particularly useful in identifying children at the greatest risk for future exacerbation. Additional studies are needed to determine whether latent classes correspond to meaningful phenotypes for the purpose of personalized treatment.
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- 2020
7. Benefits and Risks of Long-Term Asthma Management in Children: Where Are We Heading?
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Hengameh H. Raissy and H. William Kelly
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medicine.medical_specialty ,Time Factors ,Adolescent ,Omalizumab ,Toxicology ,Anti-asthmatic Agent ,Drug Administration Schedule ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,030225 pediatrics ,Administration, Inhalation ,medicine ,Humans ,Pharmacology (medical) ,Anti-Asthmatic Agents ,030212 general & internal medicine ,Dosing ,Zafirlukast ,Child ,Intensive care medicine ,Adverse effect ,Glucocorticoids ,Montelukast ,Asthma ,Pharmacology ,business.industry ,Infant, Newborn ,Infant ,medicine.disease ,Child, Preschool ,Practice Guidelines as Topic ,Physical therapy ,Drug Therapy, Combination ,business ,medicine.drug - Abstract
International guidelines provide recommendations for a stepwise approach to the management of asthma in children 0-4 years old, 5-11 years old, and adolescents who are treated as adults. Therapy is aimed at two domains of control: current impairment and future risk. The long-term controller medications, inhaled corticosteroids (ICSs), ICSs in combination with long-acting β2 agonists, leukotriene receptor antagonists, and immunomodulators, exhibit different efficacies for these domains. The risk:benefit ratios of the available medications need to be carefully assessed. This review briefly presents the benefits and the potential risks of available asthma medications in children to assist the practitioner in the optimal use of asthma medications. Specifically, the systemic activity of the ICSs and how to minimize their effects on growth and adrenal activity are reviewed as well as other potential adverse effects. Dosing strategies such as intermittent therapy are also assessed.
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- 2016
8. Emerging Therapies in the Treatment of Early Childhood Wheeze
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Elissa M. Abrams and Hengameh H. Raissy
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Pulmonary and Respiratory Medicine ,Childhood asthma ,Pediatrics ,medicine.medical_specialty ,business.industry ,Inhaled corticosteroids ,Acquired immune system ,medicine.disease ,Azithromycin ,Pharmacotherapy Update ,medicine.anatomical_structure ,Wheeze ,Pediatrics, Perinatology and Child Health ,medicine ,Immunology and Allergy ,Early childhood ,medicine.symptom ,business ,Respiratory tract ,Asthma ,medicine.drug - Abstract
Phenotypic variation in asthma, especially early childhood asthma, is increasingly recognized. Although inhaled corticosteroids are recommended as first-line therapy, it has less efficacy in controlling intermittent wheeze due to viral-induced symptoms in early childhood. This article reviews 2 emerging therapies in particular for early childhood wheeze: azithromycin and bacterial lysate therapy. Azithromycin's effects are both antibacterial and anti-inflammatory, and it has been shown in 2 studies in preschoolers to prevent progression to severe respiratory tract infection and decrease duration of wheeze. Bacterial lysates work at multiple stages in the innate and adaptive immune response and have been shown to decrease mean wheeze duration in particular in the preschool age. More research is required although both therapies offer a promising future approach, in particular in the nonatopic preschool wheezer, as we move toward a more personalized approach to childhood asthma.
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- 2019
9. Asthma Guidelines Priority Topics: Intermittent Inhaled Corticosteroid Therapy and Inhaled Corticosteroids with Long Acting Beta-Agonists as Reliever Therapy
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Kathryn V. Blake and Hengameh H. Raissy
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,business.industry ,Inhaled corticosteroids ,medicine.disease ,respiratory tract diseases ,Pharmacotherapy Update ,Long acting beta ,Corticosteroid therapy ,immune system diseases ,Pediatrics, Perinatology and Child Health ,medicine ,Immunology and Allergy ,Intensive care medicine ,Topic areas ,business ,Asthma - Abstract
The National Asthma Education and Prevention Program Guidelines for the Diagnosis and Management of Asthma will update the guidelines on 6 topic areas. This review summarizes the findings for the charge to assess effectiveness of intermittent inhaled corticosteroid therapy with and without long-acting beta-agonist therapy in children 0 to 4 years of age, and children and adults 5 years and older. The complete report can be found on the Agency for Healthcare Research and Quality website.
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- 2019
10. Personalized Medicine in Preschool Children with Asthma
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Hengameh H. Raissy and Kathryn V. Blake
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,business.industry ,medicine.disease ,Asthma management ,Early life ,Pharmacotherapy Update ,03 medical and health sciences ,0302 clinical medicine ,030228 respiratory system ,Family medicine ,Pediatrics, Perinatology and Child Health ,medicine ,Immunology and Allergy ,030212 general & internal medicine ,Personalized medicine ,business ,Asthma - Abstract
A growing body of literature has investigated optimizing asthma management by identifying phenotypes and biomarkers to guide the treatment. In particular, management of asthma in preschool children remains challenging due to different phenotype presentation in early life. The focus of this review is to summarize the recent data on personalized medicine in management of preschool children with wheezing.
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- 2017
11. A Proof of Concept Study to Detect Urease Producing Bacteria in Lungs Using Aerosolized13C-Urea
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Lea Davies, Graham S. Timmins, Michelle Harkins, Theresa Heynekamp, Zachary D. Sharp, H. William Kelly, and Hengameh H. Raissy
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0301 basic medicine ,Pulmonary and Respiratory Medicine ,Spirometry ,medicine.medical_specialty ,Urease ,Physical examination ,Investigational device exemption ,Cystic fibrosis ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Immunology and Allergy ,Aerosolization ,medicine.diagnostic_test ,Inhalation ,biology ,business.industry ,medicine.disease ,Surgery ,Nebulizer ,030104 developmental biology ,030228 respiratory system ,Anesthesia ,Pediatrics, Perinatology and Child Health ,biology.protein ,business - Abstract
This is a “proof of concept” study to determine whether inhalation of 13C-urea can be safely used to detect the presence of urease producing bacteria in the airways of patients with cystic fibrosis (CF) by detecting 13CO2 in breath. This was a prospective, 2-part, open label, single-center, single-arm, single-administration, dose-escalation investigational device exemption trial. First, the safety of 20 and 50 mg inhaled 13C-urea was evaluated in 6 healthy adult participants. Then, 3 adult CF participants colonized with Pseudomonas aeruginosa were enrolled for each dose of inhaled 13C-urea. The safety of inhaled 13C-urea was assessed by spirometry and physical examination. 13C-urea was administered using a jet nebulizer, followed by serial spirometry (10 min and 30 min post inhalation) and collection of exhaled breath at 5, 10, and 15 min post inhalation. There was no clinical significant change in any of the spirometry values compared to baseline in healthy participants and CF patients. Mean of 13CO2/12C...
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- 2016
12. Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations
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Daniel J, Jackson, Leonard B, Bacharier, David T, Mauger, Susan, Boehmer, Avraham, Beigelman, James F, Chmiel, Anne M, Fitzpatrick, Jonathan M, Gaffin, Wayne J, Morgan, Stephen P, Peters, Wanda, Phipatanakul, William J, Sheehan, Michael D, Cabana, Fernando, Holguin, Fernando D, Martinez, Jacqueline A, Pongracic, Sachin N, Baxi, Mindy, Benson, Kathryn, Blake, Ronina, Covar, Deborah A, Gentile, Elliot, Israel, Jerry A, Krishnan, Harsha V, Kumar, Jason E, Lang, Stephen C, Lazarus, John J, Lima, Dayna, Long, Ngoc, Ly, Jyothi, Marbin, James N, Moy, Ross E, Myers, J Tod, Olin, Hengameh H, Raissy, Rachel G, Robison, Kristie, Ross, Christine A, Sorkness, Robert F, Lemanske, and Lindsay, Texter
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Male ,Pediatrics ,Peak Expiratory Flow Rate ,Growth ,Anti-asthmatic Agent ,Medical and Health Sciences ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,030212 general & internal medicine ,Anti-Asthmatic Agents ,Child ,Lung ,Fluticasone ,media_common ,Pediatric ,Inhalation ,General Medicine ,medicine.anatomical_structure ,6.1 Pharmaceuticals ,Child, Preschool ,Administration ,Respiratory ,Female ,Drug ,medicine.drug ,medicine.medical_specialty ,media_common.quotation_subject ,Clinical Trials and Supportive Activities ,Fluticasone propionate ,Article ,Dose-Response Relationship ,03 medical and health sciences ,Double-Blind Method ,Clinical Research ,General & Internal Medicine ,Administration, Inhalation ,medicine ,and Blood Institute AsthmaNet ,Humans ,Albuterol ,Preschool ,Asthma ,Dose-Response Relationship, Drug ,business.industry ,Evaluation of treatments and therapeutic interventions ,National Heart ,medicine.disease ,030228 respiratory system ,business - Abstract
BackgroundAsthma exacerbations occur frequently despite the regular use of asthma-controller therapies, such as inhaled glucocorticoids. Clinicians commonly increase the doses of inhaled glucocorticoids at early signs of loss of asthma control. However, data on the safety and efficacy of this strategy in children are limited.MethodsWe studied 254 children, 5 to 11 years of age, who had mild-to-moderate persistent asthma and had had at least one asthma exacerbation treated with systemic glucocorticoids in the previous year. Children were treated for 48 weeks with maintenance low-dose inhaled glucocorticoids (fluticasone propionate at a dose of 44 μg per inhalation, two inhalations twice daily) and were randomly assigned to either continue the same dose (low-dose group) or use a quintupled dose (high-dose group; fluticasone at a dose of 220 μg per inhalation, two inhalations twice daily) for 7 days at the early signs of loss of asthma control ("yellow zone"). Treatment was provided in a double-blind fashion. The primary outcome was the rate of severe asthma exacerbations treated with systemic glucocorticoids.ResultsThe rate of severe asthma exacerbations treated with systemic glucocorticoids did not differ significantly between groups (0.48 exacerbations per year in the high-dose group and 0.37 exacerbations per year in the low-dose group; relative rate, 1.3; 95% confidence interval, 0.8 to 2.1; P=0.30). The time to the first exacerbation, the rate of treatment failure, symptom scores, and albuterol use during yellow-zone episodes did not differ significantly between groups. The total glucocorticoid exposure was 16% higher in the high-dose group than in the low-dose group. The difference in linear growth between the high-dose group and the low-dose group was -0.23 cm per year (P=0.06).ConclusionsIn children with mild-to-moderate persistent asthma treated with daily inhaled glucocorticoids, quintupling the dose at the early signs of loss of asthma control did not reduce the rate of severe asthma exacerbations or improve other asthma outcomes and may be associated with diminished linear growth. (Funded by the National Heart, Lung, and Blood Institute; STICS ClinicalTrials.gov number, NCT02066129 .).
- Published
- 2018
13. Challenges in assessing the efficacy of systemic corticosteroids for severe wheezing episodes in preschool children
- Author
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Theresa W. Guilbert, Leonard B. Bacharier, David T. Mauger, Wanda Phipatanakul, Stanley J. Szefler, Susan Boehmer, Avraham Beigelman, Anne M. Fitzpatrick, Daniel J. Jackson, Sachin N. Baxi, Mindy Benson, Carey-Ann D. Burnham, Michael D. Cabana, Mario Castro, James F. Chmiel, Ronina Covar, Michael Daines, Jonathan M. Gaffin, Deborah A. Gentile, Fernando Holguin, Elliot Israel, H. William Kelly, Stephen C. Lazarus, Robert F. Lemanske, Ngoc Ly, Kelley Meade, Wayne Morgan, James Moy, J. Tod Olin, Stephen P. Peters, Jacqueline A. Pongracic, Hengameh H. Raissy, Kristie Ross, William J. Sheehan, Christine Sorkness, W. Gerald Teague, Shannon Thyne, Fernando D. Martinez, Lisa Bartnikas, Alisha Bouzaher, Christopher Burke, Matthew Cavanaugh, Julia Chen, Elizabeth Cunningham, Amparito Cunningham, James Friedlander, Enal Hindi, David Kantor, Perdita Permaul, Devako Rao, Melinda Rossi, Doris Schierembergg, Kynda Schneider, Jennifer Troung, Dale Umetsu, Joseph Zhou, Jill Chmielewski, Anna Fishbein, Iliana Flexas, Ramsay Fuleihan, Rajesh Kumar, James Lane, Melanie Makhija, Louis Martos, Brandon Parker, Benjamin Prince, Nashmia Qamar, Mary Riordan, Rachel Robinson, Waheeda Samady, Christine Szychlinski, Daniel Tsang, Christopher Codispoti, Juan Fu, Grace Li, Diana Munoz-Mendoza, Benjamin Thompson, Melanie Gleason, Sakari Graves, Jonathan Malka, Melanie Phillips, Gayle Spears, D. Sundstrom, Michael White, Christina Batson, Lea Davies, Franceska Kelly, Esmeralda Morales, Abby Redway, Mary Spicher, Lauren Kaminski, Megan R. Knutson, Kelly Miller, Jennifer Promer, Sheila Turcsanyi, Tanya Watson, Shean Aujla, John Broyles, Hey Chong, Patricia Dubin, Jonathan Finder, Todd D. Green, Lori Holt, Adam Kufen, Geoffrey Kurland, Rose Lanzo, David Nash, Julianne Parente, Catherine Smith, Jonathan Spahr, Daniel J. Weiner, Daniel Craven, Danielle Goetz, Meeghan Hart, Leigh A. Kerns, Laurie Logan, Ross Myers, Laura Veri, Erica Butler, Jennifer Maiolo, Sara Misplay, David Skoner, Glennys Smith, Wanda Caldwell, Courtney Dula, Alysa Ellis, Caroline Horner, Lila Kertz, Tina Norris, Katherine Rivera-Spoljaric, Oscar Rodriguez, Robert Strunk, Jessica Bowman, Vicky Bowyer, Judy Gonzales-Vargas, Sara Hawkey, Susannah McCormick, Michelle McKean, Dan Shapiro, Katherine Tom, Jason Decker, Keonna Harrison, Dayna Long, Jyothi Marbin, Robert Mok, Cindy Nelson-Purdy, Dennis Ren, Hollie Stessel, Deb Green, Denise Thompson-Batt, Kristin Wavell, Donna Wolf, Timothy Beaty, Alice C. Bruce, Karen DeMuth, Jennifer Dodds, Shaneka Douglas, Dawn M. Simon, Denise Whitlock, Shanae Brown, Matthew Bowman, Loretta Doty, Linda Ferrari, Beth Gern, Dave Mauger, Aimee Merchlinski, James Schmidt, Daniel Tekely, Lindsay Texter, Angela Updegrave, and Ronald Zimmerman
- Subjects
Pediatrics ,medicine.medical_specialty ,Allergy ,Adrenal cortex hormones ,Immunology ,education ,MEDLINE ,Article ,03 medical and health sciences ,0302 clinical medicine ,Adrenal Cortex Hormones ,030225 pediatrics ,Administration, Inhalation ,and Blood Institute's AsthmaNet ,medicine ,Immunology and Allergy ,Humans ,Respiratory sounds ,Child ,Preschool ,Lung ,Asthma ,Respiratory Sounds ,medicine.diagnostic_test ,Inhalation ,business.industry ,National Heart ,medicine.disease ,Clinical trial ,medicine.anatomical_structure ,030228 respiratory system ,Child, Preschool ,Administration ,business - Abstract
Summary This letter addresses the controversial issue of the use of oral corticosteroids during wheezing exacerbations in preschool-aged children by demonstrating findings of a prematurely terminated multi-center clinical trial, discussing lessons learned, and suggesting future directions.
- Published
- 2018
14. Adolescent Asthma Pharmacotherapy in a State of Flux
- Author
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Hengameh H. Raissy and Kathryn V. Blake
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,education.field_of_study ,business.industry ,β2 agonists ,Population ,Alternative medicine ,Asthma medication ,medicine.disease ,Pharmacotherapy Update ,Food and drug administration ,Pharmacotherapy ,Anesthesia ,Pediatrics, Perinatology and Child Health ,medicine ,Immunology and Allergy ,business ,education ,Intensive care medicine ,Asthma - Abstract
Recently, the United States Food and Drug Administration (FDA) elected not to approve a once-daily inhaled corticosteroid/long-acting β2 agonist combination product in 12-17-year-old patients due to lack of sufficient data, despite approval of previous combination products with similar levels of supporting evidence. As the FDA's stance toward adolescent data is changing, the opportunity to learn about their response to asthma medication has now arisen. A review of the relevant issues pertinent to pharmacotherapy of asthma in the 12-17-year-old population is discussed in this review.
- Published
- 2015
15. The evaluation of thioridazine as a hematopoietic progenitor cell mobilizing agent in healthy human subjects
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Alexandre Chigaev, Hengameh H. Raissy, Ronald M. Schrader, Larry A. Sklar, Stuart S. Winter, and Nicole D. Stephens
- Subjects
Adult ,Male ,CD34 ,Antigens, CD34 ,Integrin alpha4beta1 ,Pharmacology ,CXCR4 ,Article ,Cell Adhesion ,Humans ,Medicine ,Pharmacology (medical) ,Progenitor cell ,Hematopoietic Stem Cell Mobilization ,Dose-Response Relationship, Drug ,Thioridazine ,business.industry ,Plerixafor ,Granulocyte colony-stimulating factor ,medicine.anatomical_structure ,Female ,Bone marrow ,Stem cell ,business ,medicine.drug - Abstract
Adhesion molecules comprise a large class of proteins that control the trafficking of hematopoietic progenitor cells between the bone marrow compartment and peripheral blood. The normal trafficking of blood-forming cells is dependent upon the controlled regulation of CXCR4, LFA-1 and VLA-4-mediated binding and unbinding events involving stromal elements.1, 2 The mobilization of hematopoietic progenitor cells has been exploited for numerous medical conditions, including the use of erythropoietin for the harvest of autologous red cells transfusions, granulocyte colony stimulating factor (G-CSF) for the release of granulocytes to treat chemotherapy-induced myelosuppression, and plerixafor for the mobilization of CD34 + HPCs cells in autologous stem cell transplantation.3 Autologous and allogeneic stem cell transplantation remains an important therapeutic option for patients who require intensified chemotherapy for a variety of indications. Autologous stem cells were initially directly harvested from the bone marrow compartments of patients prior to receiving cytotoxic therapies. Advances in clinical therapy have allowed hematopoietic progenitor cells (HPCs) to be harvested from the peripheral blood. In human subjects, HPCs comprise a very small faction of peripheral blood mononuclear cells (1 cell/1,000; or 0.1%). Such efforts have become vastly more efficient with the utilization of HPC chemical stimulants, termed mobilizing agents, which enhance the release of CD34+ HPCs from the bone marrow compartment into the peripheral blood for harvest.3-5 However, a number of problems related to the failure to mobilize sufficient numbers of CD34+ HPCs in donors or patients still exist,3, 5 necessitating further efforts to improve stem cell mobilization regimens to be short and maximally efficient. Repurposing (repositioning) of existing drugs can potentially provide one of the approaches to achieve this goal.6 Multiple hematological side effects have been reported to result from treatment with psychoactive phenothiazines. These reported toxicities include leucopenia, granulocytopenia, thrombocytopenia, agranulocytosis, and bone marrow aplasia.7-9 Until recently, the physiological mechanism causing these potentially life-threatening blood dyscrasias was unknown. However, recently we discovered that phenothiazines can almost instantaneously antagonize VLA-4 dependent cell adhesion and, after administration of thioridazine, HPCs could be rapidly mobilized into the peripheral blood in a murine model.10 We proposed that by interfering with VLA-4-mediated cell-cell adhesion involving HPCs in the bone marrow, phenothiazines might mobilize cells from the bone marrow niche. This phenomenon might help to explain the cellular mechanisms behind the frequent observation of dyserthropoeisis in patients who underwent treatment with thioridazine for psychosis.11, 12 Because the time-course for thioridazine-induced stem cell mobilization in human remains unknown, we hypothesized that thioridazine could be employed as a chemical means to mobilize CD34+ progenitor cells for peripheral blood collection. We thus designed an open-label, prospective, non-randomized feasibility clinical trial to assess the mobilizing capacity of thioridazine in healthy individuals.
- Published
- 2015
16. Tiotropium Bromide in Children and Adolescents with Asthma
- Author
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Hengameh H. Raissy and H. William Kelly
- Subjects
medicine.medical_specialty ,Adolescent ,Muscarinic Antagonists ,Placebo ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Tiotropium Bromide ,Intensive care medicine ,Child ,Lung function ,Asthma ,biology ,business.industry ,Tiotropium bromide ,Lama ,biology.organism_classification ,medicine.disease ,humanities ,respiratory tract diseases ,Bronchodilator Agents ,Clinical trial ,Regimen ,Phenotype ,Clinical Trials, Phase III as Topic ,Pediatrics, Perinatology and Child Health ,Physical therapy ,business ,human activities ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Evidence is emerging on the use of long-acting muscarinic antagonists (LAMAs) in the management of asthma. Tiotropium bromide (Spiriva® Respimat®) is the only LAMA approved in children and adolescents. As the use of tiotropium becomes more common in clinical practice, it is necessary to review the existing data to identify patients who may benefit from the addition of this medication to their daily asthma regimen. This review discusses recent evidence on the safety and efficacy of tiotropium bromide in the management of asthma in children and adolescents. Current data support that tiotropium bromide has a bronchodilator effect, as evident by improvements in acute lung function compared with placebo; however, data are not yet available to present a stepwise approach or identify phenotypes that would benefit from the addition of tiotropium bromide. Well-designed studies are needed to compare the different step-up options to tiotropium bromide and provide an evidence-based stepwise approach for the management of asthma in children. Furthermore, study design should include identification of phenotypes that might experience a better clinical response to tiotropium bromide compared with other adjunct medications.
- Published
- 2017
17. Overweight/obesity status in preschool children associates with worse asthma but robust improvement on inhaled corticosteroids
- Author
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Hengameh H. Raissy, Michael D. Cabana, Wanda Phipatanakul, David T. Mauger, Fernando D. Martinez, Daniel J. Jackson, Theresa W. Guilbert, Robert S. Zeiger, Robert F. Lemanske, Anne M. Fitzpatrick, Jacqueline A. Pongracic, Fernando Holguin, Robert C. Strunk, Monica Tang, Stanley J. Szefler, Leonard B. Bacharier, Ronina A. Covar, and Jason E. Lang
- Subjects
Male ,medicine.medical_specialty ,Exacerbation ,medicine.drug_class ,Immunology ,Overweight ,Placebo ,Article ,Body Mass Index ,03 medical and health sciences ,0302 clinical medicine ,Adrenal Cortex Hormones ,Internal medicine ,Administration, Inhalation ,medicine ,Immunology and Allergy ,Humans ,030212 general & internal medicine ,Anti-Asthmatic Agents ,Obesity ,Asthma ,business.industry ,Emergency department ,medicine.disease ,030228 respiratory system ,Child, Preschool ,Disease Progression ,Corticosteroid ,Female ,medicine.symptom ,business ,Body mass index - Abstract
Background Overweight/obesity (OW) is linked to worse asthma and poorer inhaled corticosteroid (ICS) response in older children and adults. Objective We sought to describe the relationships between OW and asthma severity and response to ICS in preschool children. Methods This post hoc study of 3 large multicenter trials involving 2- to 5-year-old children compared annualized asthma symptom days and exacerbations among normal weight (NW) (body mass index: 10th-84th percentiles) versus OW (body mass index: ≥85th percentile) participants. Participants had been randomized to daily ICS, intermittent ICS, or daily placebo. Simple and multivariable linear regression was used to compare body mass index groups. Results Within the group not treated with a daily controller, OW children had more asthma symptom days (90.7 vs 53.2, P = .020) and exacerbations (1.4 vs 0.8, P = .009) thanNW children did. Within the ICS-treated groups, OW and NW children had similar asthma symptom days (daily ICS: 47.2 vs 44.0 days, P = .44; short-term ICS: 61.8 vs 52.9 days, P = .46; as-needed ICS: 53.3 vs 47.3 days, P = .53), and similar exacerbations (daily ICS: 0.6 vs 0.8, P = .10; short-term ICS: 1.1 vs 0.8 days, P = .25; as-needed ICS: 1.0 vs 1.1, P = .72). Compared with placebo, daily ICS in OW led to fewer annualized asthma symptom days (90.7 vs 41.2, P = .004) and exacerbations (1.4 vs 0.6, P = .006), while similar protective ICS effects were less apparent among NW. Conclusions In preschool children off controller therapy, OW is associated with greater asthma impairment and exacerbations. However, unlike older asthmatic patients, OW preschool children do not demonstrate reduced responsiveness to ICS therapy.
- Published
- 2017
18. Asthma across the ages: Knowledge gaps in childhood asthma
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Daniel J. Jackson, Hengameh H. Raissy, Stanley J. Szefler, Wanda Phipatanakul, George P. Giacoia, James F. Chmiel, Heber C. Nielsen, Anne M. Fitzpatrick, and Thomas P. Green
- Subjects
Childhood asthma ,medicine.medical_specialty ,Pediatrics ,business.industry ,Immunology ,Evidence-based medicine ,Disease ,medicine.disease ,Child health ,Human development (humanity) ,Family medicine ,Asthma mortality ,medicine ,Immunology and Allergy ,Early childhood ,business ,Asthma - Abstract
The Eunice Kennedy Shriver National Institute of Child Health and Human Development convened an Asthma Group in response to the Best Pharmaceuticals for Children Act. The overall goal of the Best Pharmaceuticals for Children Act Program is to improve pediatric therapeutics through preclinical and clinical drug trials that lead to drug-labeling changes. Although significant advances have been made in the understanding and management of asthma in adults with appropriately labeled medications, less information is available on the management of asthma in children. Indeed, many medications are inadequately labeled for use in children. In general, the younger the child, the less information there is available to guide clinicians. Because asthma often begins in early childhood, it is incumbent on us to continue to address the primary questions raised in this review and carefully evaluate the medications used to manage asthma in children. Meanwhile, continued efforts should be made in defining effective strategies that reduce the risk of exacerbations. If the areas of defined need are addressed in the coming years, namely prevention of exacerbations and progression of disease, as well as primary intervention, we will see continuing reduction in asthma mortality and morbidity along with improved quality of life for children with asthma.
- Published
- 2014
19. Vitamin D and Asthma: Association, Causality, or Intervention?
- Author
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Hengameh H. Raissy and Kathryn V. Blake
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Pediatrics ,business.industry ,medicine.disease ,Causality ,Pharmacotherapy Update ,Clinical trial ,Intervention (counseling) ,Pediatrics, Perinatology and Child Health ,Physical therapy ,Vitamin D and neurology ,Immunology and Allergy ,Medicine ,Observational study ,Dosing ,business ,Association (psychology) ,Asthma - Abstract
Many observational studies have investigated the potential association between vitamin D and asthma. However, it is difficult to find a temporal causal relationship in cross-sectional or observational studies. This review presents recent clinical trials and the evidence of association between vitamin D and asthma in different patient populations and asthma status. Well-designed clinical trials are warranted in order to define the optimal level of vitamin D, as well as dosing and duration of vitamin D supplementation, in pediatric patients.
- Published
- 2015
20. Inhaled corticosteroids: the last 5 years
- Author
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H. William Kelly and Hengameh H. Raissy
- Subjects
medicine.medical_specialty ,business.industry ,Small airways ,Inhaled corticosteroids ,General Medicine ,Asthma management ,medicine.disease ,Airway disease ,Anesthesia ,Pharmacogenomics ,Medicine ,Adverse effect ,business ,Intensive care medicine ,Persistent asthma ,Asthma - Abstract
This review will highlight new information on the use of inhaled corticosteroids (ICSs) for management of asthma with regard to long-term side effects and new treatment approaches. Variability in response to ICSs has been increasingly recognized and contribution of pharmacogenomic, phenotypes and environmental factors have been identified and discussed here. As ICSs remain the cornerstone of persistent asthma management, the CAMP trial provides more data in long-term adverse effect of ICSs. In order to minimize the side effects of ICSs, different asthma management approaches have been proposed in different patient populations. In addition, potential advantages of fine particle ICSs for improving small airway disease have been discussed.
- Published
- 2013
21. Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma
- Author
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Wayne J. Morgan, Michael D. Cabana, Cori L. Daines, W. A. Gower, Wanda Phipatanakul, Rachel G. Robison, Stephen C. Lazarus, Harsha Vardhan Hampasandra Madan Kumar, Jyothi Marbin, Fernando D. Martinez, Hengameh H. Raissy, James N. Moy, Jonathan M. Gaffin, Michael E. Wechsler, Elliot Israel, Kristie R. Ross, Shannon Thyne, Ngoc P. Ly, Ross Myers, Susan J. Boehmer, R. F. Lemanske, Stephen P. Peters, Ian M. Paul, Kathryn V. Blake, Deborah A. Gentile, Michael O. Daines, Sachin N. Baxi, Fernando Holguin, John J. Lima, Avraham Beigelman, William J. Sheehan, C. A. Sorkness, J. T. Olin, Stanley J. Szefler, M. Benson, Leonard B. Bacharier, D. J. Jackson, Ronina A. Covar, Jason E. Lang, Anne M. Fitzpatrick, James F. Chmiel, Jacqueline A. Pongracic, and David T. Mauger
- Subjects
Male ,medicine.medical_specialty ,Fever ,Clinical Trials and Supportive Activities ,Pain ,Ibuprofen ,Kaplan-Meier Estimate ,Medical and Health Sciences ,Article ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,NIH/NHLBI AsthmaNet ,Randomized controlled trial ,Double-Blind Method ,law ,Interquartile range ,Clinical Research ,030225 pediatrics ,Internal medicine ,General & Internal Medicine ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Prospective cohort study ,Child ,Preschool ,Lung ,Asthma ,Acetaminophen ,Pediatric ,business.industry ,Incidence (epidemiology) ,Incidence ,Infant ,General Medicine ,medicine.disease ,Anesthesia ,Respiratory ,Female ,business ,Mild persistent asthma ,medicine.drug - Abstract
BackgroundStudies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking.MethodsIn a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial.ResultsParticipants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P=0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P=0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P=0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P=0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P=0.94), or adverse events.ConclusionsAmong young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.).
- Published
- 2016
22. Macrolides for Acute Wheezing Episodes in Preschool Children
- Author
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Kathryn V. Blake and Hengameh H. Raissy
- Subjects
Pulmonary and Respiratory Medicine ,Pediatrics ,medicine.medical_specialty ,Asthma exacerbations ,Exacerbation ,business.industry ,medicine.drug_class ,Antibiotics ,Antibacterial effect ,medicine.disease ,Azithromycin ,respiratory tract diseases ,Pharmacotherapy Update ,03 medical and health sciences ,Panel report ,0302 clinical medicine ,030228 respiratory system ,Pediatrics, Perinatology and Child Health ,Immunology and Allergy ,Medicine ,030212 general & internal medicine ,Airway ,business ,Asthma ,medicine.drug - Abstract
The National Asthma Education and Prevention Program's Expert Panel Report 3, Guidelines for the Diagnosis and Management of Asthma does not recommend antibiotics for the management of acute episodes of asthma exacerbation. Macrolides seem to have some potential effect beyond or in addition to their antibacterial effect. It has been reported that macrolides may potentially benefit patients with chronic inflammatory airway diseases due to their antibacterial, antiviral, and/or anti-inflammatory effects. This review presents recent data on use of azithromycin in prevention and management of acute exacerbation of respiratory symptoms in infants and young children.
- Published
- 2016
23. Treatment of Pediatric Asthma with Proton Pump Inhibitors: Three Strikes, Game Over
- Author
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Hengameh H. Raissy and Kathryn V. Blake
- Subjects
Pulmonary and Respiratory Medicine ,education.field_of_study ,medicine.medical_specialty ,Asthma exacerbations ,business.industry ,Population ,Reflux ,Disease ,medicine.disease ,Surgery ,Internal medicine ,Asthma control ,Pediatrics, Perinatology and Child Health ,medicine ,Immunology and Allergy ,In patient ,education ,business ,Pediatric asthma ,Asthma - Abstract
Empiric use of proton pump inhibitors (PPI) for the treatment of poorly controlled asthma has increased substantially in the past decade under the presumption that gastroesophageal reflux is precipitating symptoms. No PPI has a Food and Drug Administration (FDA) approved indication for the treatment of asthma symptoms. Use has been driven by data indicating that up to 80% of children and adults with asthma have reflux by pH probe monitoring and that nearly half of patients lack typical reflux symptoms. Data from controlled studies of adults have shown only a minimal improvement in peak expiratory flow with PPI use in the overall population, with only a slightly larger improvement in patients with diagnosed gastroesophageal reflux disease, and no effect on asthma exacerbation rate in one study. The single largest placebo-controlled study in children with poorly controlled asthma without gastroesophageal reflux symptoms found no improvement in any indices of asthma control, even in children with gastroesoph...
- Published
- 2012
24. Early Administration of Azithromycin and Prevention of Severe Lower Respiratory Tract Illnesses in Preschool Children With a History of Such Illnesses: A Randomized Clinical Trial
- Author
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Jonathan M. Gaffin, Mario Castro, W. Gerald Teague, David T. Mauger, Carey-Ann D. Burnham, Michael Daines, Theresa W. Guilbert, H. William Kelly, Susan J. Boehmer, Elliot Israel, Jacqueline A. Pongracic, Christine A. Sorkness, Deborah A. Gentile, Anne M. Fitzpatrick, Stephen C. Lazarus, Avraham Beigelman, Fernando D. Martinez, James N. Moy, James F. Chmiel, Daniel J. Jackson, Kelley Meade, William J. Sheehan, Stanley J. Szefler, Ngoc P. Ly, Fernando Holguin, Tod Olin, Stephen P. Peters, Wanda Phipatanakul, Michael D. Cabana, Robert F. Lemanske, Leonard B. Bacharier, Ronina A. Covar, Shannon Thyne, Wayne J. Morgan, Sachin N. Baxi, Hengameh H. Raissy, Kristie R. Ross, and Mindy Benson
- Subjects
Male ,Pediatrics ,Drug Resistance ,Azithromycin ,Medical and Health Sciences ,law.invention ,Randomized controlled trial ,law ,Recurrence ,Pregnancy ,Risk Factors ,Secondary Prevention ,Child ,Respiratory Tract Infections ,Lung ,Pediatric ,Respiratory tract infections ,Hazard ratio ,Absolute risk reduction ,Bacterial ,Abnormalities, Drug-Induced ,General Medicine ,Anti-Bacterial Agents ,Infectious Diseases ,6.1 Pharmaceuticals ,Disease Progression ,Female ,medicine.drug ,medicine.medical_specialty ,Clinical Trials and Supportive Activities ,Gestational Age ,Placebo ,Drug Administration Schedule ,Article ,Double-Blind Method ,Clinical Research ,Lower respiratory tract infection ,General & Internal Medicine ,Complementary and Integrative Health ,medicine ,Humans ,Adverse effect ,Preschool ,business.industry ,Prevention ,Infant, Newborn ,Infant ,Evaluation of treatments and therapeutic interventions ,medicine.disease ,Pregnancy Complications ,business - Abstract
Importance Many preschool children develop recurrent, severe episodes of lower respiratory tract illness (LRTI). Although viral infections are often present, bacteria may also contribute to illness pathogenesis. Strategies that effectively attenuate such episodes are needed. Objective To evaluate if early administration of azithromycin, started prior to the onset of severe LRTI symptoms, in preschool children with recurrent severe LRTIs can prevent the progression of these episodes. Design, Setting, and Participants A randomized, double-blind, placebo-controlled, parallel-group trial conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute’s AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by December 2014. Participants were 607 children aged 12 through 71 months with histories of recurrent, severe LRTIs and minimal day-to-day impairment. Intervention Participants were randomly assigned to receive azithromycin (12 mg/kg/d for 5 days; n = 307) or matching placebo (n = 300), started early during each predefined RTI (child’s signs or symptoms prior to development of LRTI), based on individualized action plans, over a 12- through 18-month period. Main Outcomes and Measures The primary outcome measure was the number of RTIs not progressing to a severe LRTI, measured at the level of the RTI, that would in clinical practice trigger the prescription of oral corticosteroids. Presence of azithromycin-resistant organisms in oropharyngeal samples, along with adverse events, were among the secondary outcome measures. Results A total of 937 treated RTIs (azithromycin group, 473; placebo group, 464) were experienced by 443 children (azithromycin group, 223; placebo group, 220), including 92 severe LRTIs (azithromycin group, 35; placebo group, 57). Azithromycin significantly reduced the risk of progressing to severe LRTI relative to placebo (hazard ratio, 0.64 [95% CI, 0.41-0.98], P = .04; absolute risk for first RTI: 0.05 for azithromycin, 0.08 for placebo; risk difference, 0.03 [95% CI, 0.00-0.06]). Induction of azithromycin-resistant organisms and adverse events were infrequently observed. Conclusions and Relevance Among young children with histories of recurrent severe LRTIs, the use of azithromycin early during an apparent RTI compared with placebo reduced the likelihood of severe LRTI. More information is needed on the development of antibiotic-resistant pathogens with this strategy. Trial Registration clinicaltrials.gov Identifier:NCT01272635
- Published
- 2015
25. Comparison of Inhaled Corticosteroids: What You Need to Know in Choosing a Product
- Author
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Hengameh H. Raissy and Kathryn V. Blake
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,business.industry ,Mometasone furoate ,Inhaled corticosteroids ,Ciclesonide ,medicine.disease ,Fluticasone propionate ,chemistry.chemical_compound ,Pharmacokinetics ,chemistry ,Pharmacodynamics ,Pediatrics, Perinatology and Child Health ,medicine ,Immunology and Allergy ,Dosing ,Intensive care medicine ,business ,medicine.drug ,Asthma - Abstract
Inhaled corticosteroids (ICS) are recommended by The National Asthma Education and Prevention Program's Expert Panel Report 3 for all levels of persistent asthma in the pediatric population. The recommended ICS doses are based on assessment of severity and control of asthma. The pharmacodynamics and pharmacokinetics of the current ICSs are reviewed. While comparable efficacy can be achieved with equipotent dosing, some of the newer ICSs, fluticasone propionate, mometasone furoate, and ciclesonide, have pharmacokinetic profiles that produce less risk of systemic effects. However, at high doses systemic activity increases with all ICSs. The clinicians need to weigh the benefits and risks of these different products and dosing schemes in their patients for optimal use.
- Published
- 2011
26. Pretreatment with Albuterol versus Montelukast for Exercise-Induced Bronchospasm in Children
- Author
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Hengameh H. Raissy, Franceska Marie Kelly, Michelle Harkins, and H. William Kelly
- Subjects
Cyclopropanes ,Male ,Spirometry ,Adolescent ,medicine.drug_class ,Acetates ,Sulfides ,Exercise-Induced Bronchospasm ,Bronchospasm ,Hospitals, University ,Double-Blind Method ,immune system diseases ,Forced Expiratory Volume ,Bronchodilator ,Humans ,Medicine ,Albuterol ,Pharmacology (medical) ,Exhaled breath condensate ,Anti-Asthmatic Agents ,Prospective Studies ,Child ,Montelukast ,Asthma ,Cross-Over Studies ,medicine.diagnostic_test ,business.industry ,Adrenergic beta-Agonists ,medicine.disease ,respiratory tract diseases ,Asthma, Exercise-Induced ,Anesthesia ,Quinolines ,Salbutamol ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
Study Objectives. To compare pretreatment with albuterol versus montelukast added to the current asthma regimen for protection against exercise-induced bronchospasm in children with mild-to-moderate asthma, and to determine whether cysteinyl leukotriene (Cys-LT) concentrations measured in the exhaled breath condensate correlated with response to montelukast. Design. Prospective, randomized, double-blind, double-dummy, crossover study Setting. Asthma clinic at a university-affiliated medical center. Patients. Eleven children aged 7–17 years with physician-diagnosed mild-to-moderate asthma for at least 6 months and with self-reported exercise-induced bronchospasm (defined as ≤ 15% decrease in forced expiratory volume in 1 sec [FEV1] at screening and baseline visit). Intervention. Patients were randomly assigned to receive 3–7 days of oral montelukast 5–10 mg/day or 2 puffs of an albuterol metered-dose inhaler just before an exercise challenge and then were crossed over to the alternate therapy for the last visit. Measurements and Main Results. Serial spirometry was performed before and at 0, 5, 10, 15, 30, 45, and 60 minutes after the exercise challenge at each visit. Measurement of exhaled breath condensate was performed at the screening visit and study visits 1 and 2. The primary outcome was the maximum change in FEV1 after exercise. Secondary outcomes were the area under the curve for FEV1 (expressed as percentage decrease from baseline) during the first 60 minutes (AUC0–60) after exercise and the proportion of patients in whom exercise-induced bronchospasm was prevented (defined as < 15% decrease in FEV1 after exercise challenge). The mean ± SD maximum decrease in FEV1 was 27.5 ± 7.9% at baseline. Patients receiving montelukast had an 18.3 ± 13.7% decrease in FEV1 compared with 0.7 ± 1.6% in patients receiving albuterol (p=0.002, paired t test). Exercise-induced bronchospasm was prevented in 100% of the patients receiving albuterol compared with 55% receiving montelukast (p
- Published
- 2008
27. Comparison of the Dose Response to Levalbuterol with and without Pretreatment with S-Albuterol After Methacholine-Induced Bronchoconstriction
- Author
-
H. William Kelly, Anna Esparham, Hengameh H. Raissy, and Michelle Harkins
- Subjects
Adult ,Adolescent ,medicine.drug_class ,Bronchoconstriction ,Ipratropium bromide ,Nitric Oxide ,Bronchial Provocation Tests ,Cholinergic Antagonists ,Bronchoconstrictor Agents ,Double-Blind Method ,immune system diseases ,Forced Expiratory Volume ,Bronchodilator ,Levalbuterol ,Humans ,Medicine ,Albuterol ,Pharmacology (medical) ,Prospective Studies ,Methacholine Chloride ,Cross-Over Studies ,Dose-Response Relationship, Drug ,business.industry ,Ipratropium ,Area under the curve ,Stereoisomerism ,Middle Aged ,respiratory system ,Crossover study ,Asthma ,Bronchodilator Agents ,respiratory tract diseases ,Breath Tests ,Area Under Curve ,Anesthesia ,Exhaled nitric oxide ,Salbutamol ,Methacholine ,business ,Drug Antagonism ,medicine.drug - Abstract
Study Objective. To determine the effect of S-albuterol on the dose response to levalbuterol in patients with moderate bronchoconstriction induced by a methacholine challenge. Design. Prospective, randomized, double-blind, placebo-controlled, crossover study. Setting. University-affiliated clinical trial center. Patients. Twenty-two adults with mild, stable asthma. Intervention. At the screening visit, patients were switched from their β2-agonist to ipratropium bromide for use as an as-needed rescue therapy. At the baseline visit 2–6 days later, the provocative concentration of methacholine to induce a 30% decrease in forced expiratory volume in 1 second (FEV1 PC30) was determined, followed by a nebulized racemic albuterol dose-response study with three doses of albuterol, to familiarize patients with the procedures. At visits 2 and 3, patients were randomly assigned to receive nebulized normal saline placebo or S-albuterol 5 mg before the methacholine challenge and were administered three escalating doses of levalbuterol after the challenge. Measurements and Main Results. Area under the curve for FEV1 over 40 minutes (AUC0–40) after administration of levalbuterol was the primary outcome, with slope of FEV1 as the secondary outcome. In addition, the fraction of exhaled nitric oxide (FeNO) was measured before and after the challenges. In the 17 patients who met criteria for completion, no deleterious effect for S-albuterol was found for FEV1 PC30, AUC0–40 FEV1, or the FEV1 slope0–40. However, S-albuterol reduced the provocative concentration of methacholine to induce a 20% decrease in FEV1 (PC20 0.52 ± 2.06 vs 0.39 ± 1.58 mg/ml, placebo vs S-albuterol, p=0.044) but did not affect FeNO. Conclusion. A single high dose of S-albuterol did not alter the bronchodilator response to levalbuterol. The effect on bronchial responsiveness requires further study.
- Published
- 2007
28. Airway obstruction worsens in young adults with asthma who become obese
- Author
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Robert C. Strunk, Ryan Colvin, Leonard B. Bacharier, Anne Fuhlbrigge, Erick Forno, Ana Maria Arbelaez, Kelan G. Tantisira, Paul Williams, Mary V. Lasley, Tamara Chinn, Michele Hinatsu, Clifton T. Furukawa, Leonard C. Altman, Frank S. Virant, Michael S. Kennedy, Stephen Tilles, Jonathan W. Becker, C. Warren Bierman, Dan Crawford, Thomas DuHamel, Heather Eliassen, Babi Hammond, Miranda MacLaren, Dominick A. Minotti, Chris Reagan, Gail Shapiro, Marian Sharpe, Ashley Tatum, Grace White, Timothy G. Wighton, Anne Plunkett, Nancy Madden, Susan Anderson, Mark Boehnert, Anita Feins, Amanda Gentile, Natalia Kandror, Kelly MacAulay, Ernestina Sampong, Scott Weiss, Walter Torda, Martha Tata, Sally Babigian, Peter Barrant, Linda Benson, Jose Caicedo, Tatum Calder, Christine Darcy, Anthony DeFilippo, Cindy Dorsainvil, Julie Erickson, Phoebe Fulton, Mary Grace, Jennifer Gilbert, Dirk Greineder, Stephanie Haynes, Margaret Higham, Deborah Jakubowski, Susan Kelleher, Jay Koslof, Dana Mandel, Patricia Martin, Agnes Martinez, Jean McAuliffe, Erika Nakamoto, Paola Pacella, Paula Parks, Johanna Sagarin, Kay Seligsohn, Susan Swords, Meghan Syring, June Traylor, Melissa Van Horn, Carolyn Wells, Ann Whitman, Hartmut Grasemann, Melody Miki, Melinda Solomon, Padmaja Subbarao, Ian MacLusky, Joe Reisman, Henry Levison, Anita Hall, Yola Benedet, Susan Carpenter, Jennifer Chay, Michelle Collinson, Jane Finlayson-Kulchin, Kenneth Gore, Nina Hipolito, Noreen Holmes, Erica Hoorntje, Sharon Klassen, Joseé Quenneville, Renée Sananes, Christine Wasson, Margaret Wilson, N. Franklin Adkinson, Deborah Bull, Stephanie Philips, Peyton Eggleston, Karen Huss, Leslie Plotnick, Margaret Pulsifer, Cynthia Rand, Elizabeth Aylward, Nancy Bollers, Kathy Pessaro, Barbara Wheeler, Stanley Szefler, Ronina Covar, Harold S. Nelson, Bruce Bender, Andrew Liu, D. Sundström, Melanie Phillips, Michael P. White, Melanie Gleason, Kristin Brelsford, Jessyca Bridges, Jody Ciacco, Michael Eltz, Jeryl Feeley, Michael Flynn, Tara Junk-Blanchard, Joseph Hassell, Marcia Hefner, Caroline Hendrickson, Daniel Hettleman, Charles G. Irvin, Alan Kamada, Marzena Krawiec, Gary Larsen, Sai Nimmagadda, Kendra Sandoval, Jessica Sheridan, Joseph Spahn, Gayle Spears, Trella Washington, Eric Willcutt, Ivan Cardona, Kirstin Carel, Jayna Doshi, Rich Hendershot, Jeffrey Jacobs, Neal Jain, June-ku Brian Kang, Tracy Kruzick, Harvey Leo, Beth Macomber, Jonathan Malka, Chris Mjaanes, John Prpich, Lora Stewart, Ben Song, Grace Tamesis, Robert S. Zeiger, Noah Friedman, Michael H. Mellon, Michael Schatz, Terrie Long, Travis Macaraeg, Sandra Christensen, James G. Easton, M. Feinberg, Linda L. Galbreath, Jennifer Gulczynski, Kathleen Harden, Ellen Hansen, Al Jalowayski, Elaine Jenson, Alan Lincoln, Jennie Kaufman, Shirley King, Brian Lopez, Michaela Magiari-Ene, Kathleen Mostafa, Avraham Moscona, Catherine A. Nelle, Jennifer Powers, Elsa Rodriguez, Eva Rodriguez, Karen Sandoval, Nevin W. Wilson, Hengameh H. Raissy, Aaron Jacobs, H. William Kelly, Mary Spicher, Christina Batson, Michelle Harkings, Katie McCallum, Robert Annett, Teresa Archibeque, Naim Bashir, H. Selda Bereket, Marisa Braun, Carrie Bush, Shannon C. Bush, Michael Clayton, Angel Colon-Semidey, Sara Devault, Anna Esparham, Roni Grad, David Hunt, Jeanne Larsson, Sandra McClelland, Bennie McWilliams, Elisha Montoya, Margaret Moreshead, Shirley Murphy, Barbara Ortega, David Weers, Jose Zayas, Leonard Bacharier, Denise Rodgers, Ellen Albers, Gregg Belle, Gordon R. Bloomberg, W. Patrick Buchanan, Mary Caesar, James M. Corry, Karen DeMuth, Marisa Dolinsky, Edwin B. Fisher, Stephen J. Gaioni, Emily Glynn, Bernadette D. Heckman, Debra Kemp, Lila Kertz, Claire Lawhon, Valerie Morgan, Cynthia Moseid, Tina Oliver-Welker, Diana Richardson, Elizabeth Ryan, Sharon Sagal, Thomas F. Smith, Susan Sylvia, Carl Turner, Deborah K. White, James Tonascia, Patricia Belt, Karen Collins, Betty Collison, John Dodge, Michele Donithan, Cathleen Ewing, Rosetta Jackson, Patrick May, Jill Meinert, Girlie Reyes, Michael Smith, Alice L. Sternberg, Mark L. Van Natta, Annette Wagoner, Laura Wilson, Robert Wise, Katherine Yates, Virginia Taggart, Lois Eggers, James Kiley, Howard Moore, Gang Zheng, Paul Albert, Suzanne Hurd, Sydney Parker, Pamela Randall, Margaret Wu, Michelle Cloutier, John Connett, Leona Cuttler, Frank Gilliland, Clarence E. Davis, Howard Eigen, David Evans, Meyer Kattan, Rogelio Menendez, F. Estelle R. Simons, Sanford Leikin, Robert Strunk, Reuben Cherniack, Thomas R. DuHamel, Curtis L. Meinert, Gail G. Shapiro, and Robert Zeiger
- Subjects
Adult ,Male ,Risk ,Vital capacity ,Pediatrics ,medicine.medical_specialty ,Adolescent ,Childhood obesity ,Article ,Pulmonary function testing ,Body Mass Index ,FEV1/FVC ratio ,Young Adult ,Nedocromil ,medicine ,Immunology and Allergy ,Humans ,Obesity ,Young adult ,Budesonide ,Child ,Asthma ,business.industry ,Airway obstruction ,medicine.disease ,respiratory tract diseases ,Respiratory Function Tests ,Airway Obstruction ,Child, Preschool ,Physical therapy ,Disease Progression ,Female ,business ,Body mass index ,Follow-Up Studies - Abstract
Few studies have examined how developing obesity in early adulthood affects the course of asthma.We analyzed lung function and asthma impairment and risk among nonobese children with asthma, comparing those who were obese in young adulthood with those who remained nonobese.We carried out the post hoc analysis of 771 subjects with mild to moderate asthma who were not obese (pediatric definition, body mass index [BMI]95th percentile) when enrolled in the Childhood Asthma Management Program at ages 5-12 years. The subjects were then followed to age 20 years or more. For visits at ages 20 years or more, spirometry values as percent predicted and recent asthma symptom scores and prednisone exposure were compared between 579 subjects who were nonobese at all visits and 151 who were obese (adult definition of BMI ≥ 30 kg/m(2)) on at least 1 visit (median number of visits when obese = 4, IQR 2-7).Compared with participants who were nonobese (BMI 23.4 ± 2.6 kg/m(2)), those who became obese (BMI 31.5 ± 3.8 kg/m(2)) had significant decreases in forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC) (P.0003) and FEV1 (P = .001), without differences in FVC (P = .15) during visits at ages 20 years or more. For each unit increase of BMI, FEV1 percent predicted decreased by 0.29 (P = .0009). The relationship between BMI and lung function was not confounded by sex or BMI at baseline. Asthma impairment (symptom scores) and risk (prednisone use) did not differ between the 2 groups.Becoming obese in early adulthood was associated with increased airway obstruction, without impact on asthma impairment or risk.
- Published
- 2015
29. Inspiratory Flowthrough Dry-Powder Inhalers (DPIs) in Asthmatic Children 2 to 12 Years Old
- Author
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Hengameh H. Raissy, Lea Davies, Patricia Marshik, and H. William Kelly
- Subjects
Pulmonary and Respiratory Medicine ,Asthmatic children ,Pediatrics ,medicine.medical_specialty ,Dry powder ,business.industry ,Pediatrics, Perinatology and Child Health ,measurement_unit.measuring_instrument ,Immunology and Allergy ,Medicine ,business ,Peak flow meter ,measurement_unit - Abstract
The objective of the study was to measure peak inspiratory flow (PIF) generated through Turbuhaler, Aerolizer, and Diskus inhalers in children 2 to 12 years old. An open-labeled, stratified, random...
- Published
- 2006
30. Treatment Algorithms from the Pharmacist Perspective
- Author
-
Jake Nichols, Hengameh H. Raissy, Eric Wittbrodt, and Peter Koval
- Subjects
Patient Care Team ,Bronchial Spasm ,business.industry ,Perspective (graphical) ,Pharmacist ,Pulmonary disease ,Pharmacy ,Pharmacists ,Chemist ,medicine.disease ,Asthma ,Pulmonary Disease, Chronic Obstructive ,Chronic disease ,Lung disease ,Practice Guidelines as Topic ,Humans ,Medicine ,Pharmacology (medical) ,Pharmacy Service, Hospital ,business ,Algorithm ,Algorithms - Abstract
Hospitals across the United States develop treatment algorithms for acute bronchospasm, asthma, and chronic obstructive pulmonary disease by following several different pathways. Some institutions use established national guidelines and protocols, some revise national guidelines to apply to their particular environment, and others create specific institution-related treatment algorithms with input from various departments, such as emergency medicine, respiratory therapy, and pharmacy. Although some institutions track outcomes on either a formal or an informal basis, others have not yet implemented outcomes-based programs.
- Published
- 2006
31. Urinary-Free Cortisol in Hispanic and Non-Hispanic Children with Mild Asthma and Nonasthmatic Normals
- Author
-
Hengameh H. Raissy, H. William Kelly, and Susan Scott
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Endocrinology ,business.industry ,Internal medicine ,Pediatrics, Perinatology and Child Health ,Urinary free cortisol ,Mild asthma ,medicine ,Immunology and Allergy ,business ,hormones, hormone substitutes, and hormone antagonists - Abstract
Urinary free cortisol (UFC) concentration is one of the most sensitive indicators of systemic effect of glucocorticoids. The purpose of this study was to determine normal UFC values in healthy chil...
- Published
- 2006
32. A Crossover Comparison of Fluticasone Propionate and Montelukast on Inflammatory Indices in Children with Asthma
- Author
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Hengameh H. Raissy, L. Francine Caffey, Patricia Marshik, and H. William Kelly
- Subjects
Pulmonary and Respiratory Medicine ,Relative efficacy ,medicine.drug_class ,business.industry ,Pharmacology ,medicine.disease ,Fluticasone propionate ,Pediatrics, Perinatology and Child Health ,Exhaled nitric oxide ,medicine ,Immunology and Allergy ,Corticosteroid ,business ,Montelukast ,medicine.drug ,Asthma - Abstract
Our aim was to directly compare anti-inflammatory activity, as measured by fraction of exhaled nitric oxide (FeNO), relative efficacy, and safety of a low-dose inhaled corticosteroid and a leukotri...
- Published
- 2005
33. Does Use of Inhaled Corticosteroid for Management of Asthma in Children Make Them Shorter Adults?
- Author
-
Hengameh H. Raissy and Kathryn V. Blake
- Subjects
Pulmonary and Respiratory Medicine ,Growth suppression ,Pediatrics ,medicine.medical_specialty ,business.industry ,medicine.drug_class ,Moderate asthma ,Inhaled corticosteroids ,medicine.disease ,Adult height ,Pharmacotherapy Update ,Pediatrics, Perinatology and Child Health ,medicine ,Immunology and Allergy ,Corticosteroid ,business ,Asthma - Abstract
The purpose of this review is to discuss the effect of daily inhaled corticosteroids (ICSs) on the height of children with asthma. The effect of ICSs on growth and height is dependent on the dose and the therapeutic index of the ICS; however, the effect on final adult height was not clear until recently. New data suggest that if growth suppression occurs with the use of ICSs in children, it is sustained, but not cumulative over the years. The observed reduction in the final adult height is small and does not outweigh the benefits of ICSs, and the growth effect may be minimized by use of newer ICSs and other approaches for management of asthma in children with mild to moderate asthma.
- Published
- 2013
34. Comparison of the Systemic Effects of Fluticasone Propionate and Triamcinolone Acetonide Administered in Equipotent Doses in Children with Asthma
- Author
-
Angel Colon-Semidy, Patricia Marshik, H. William Kelly, Mark R. Crowley, Hengameh H. Raissy, and Heather Wright
- Subjects
Pulmonary and Respiratory Medicine ,Triamcinolone acetonide ,business.industry ,Inhaled corticosteroids ,medicine.disease ,Crossover study ,Fluticasone propionate ,Panel report ,Pharmacokinetics ,Anesthesia ,Pediatrics, Perinatology and Child Health ,Exhaled nitric oxide ,medicine ,Immunology and Allergy ,business ,Asthma ,medicine.drug - Abstract
Equal efficacious doses of the inhaled corticosteroids can result in significant differences in systemic effects due to differences in their pharmacokinetic profile. The purpose of this study was to evaluate a model to compare systemic activity of inhaled corticosteroids given in topically equipotent doses in children. Systemic effects were measured by 24-hour urinary free cortisol (UFC) and a.m. and p.m. serum osteocalcin. Efficacy was monitored by a.m. and p.m. exhaled nitric oxide (eNO) and a.m. peak expiratory flow (PEF). Twenty-one children, 6-16 years old on inhaled corticosteroids at ≥400 μg/day beclomethasone dipropionate (BDP) equivalent were placed on BDP for a 2-week, open-label, run-in, baseline period. Patients were then randomized into a double-blind, double-dummy, crossover trial for two 3-week periods of equipotent doses of fluticasone propionate (FP) or triamcinolone acetonide (TAA) as defined by the NHLBI Expert Panel Report 2. At the end of baseline and each treatment phase patients wer...
- Published
- 2003
35. Use of Levalbuterol
- Author
-
Hengameh H. Raissy, Catherine Weeks, Edward A. Bell, and Patricia Marshik
- Subjects
medicine.medical_specialty ,β2 agonists ,business.industry ,Internal medicine ,Pediatrics, Perinatology and Child Health ,Levalbuterol ,medicine ,Pharmacology (medical) ,medicine.disease ,business ,Therapeutic Dilemma ,Asthma - Published
- 2003
36. As Needed Use of Inhaled Corticosteroids for Management of Mild Persistent Asthma in Children
- Author
-
Kathryn V. Blake and Hengameh H. Raissy
- Subjects
Pulmonary and Respiratory Medicine ,Pediatrics ,medicine.medical_specialty ,business.industry ,Inhaled corticosteroids ,medicine.disease ,Asymptomatic ,Effective dose (pharmacology) ,respiratory tract diseases ,Discontinuation ,Pharmacotherapy Update ,Regimen ,Asthma control ,Pediatrics, Perinatology and Child Health ,medicine ,Immunology and Allergy ,medicine.symptom ,business ,Mild persistent asthma ,Asthma - Abstract
The National Asthma Education and Prevention Program's Expert Panel Report 3 (EPR3), Guidelines for the Diagnosis and Management of Asthma, provides recommendations for initial assessment of asthma severity based on both impairment and risk domains. Subsequently, the follow-up visits are designed to assess asthma control and to adjust the therapy to the lowest effective dose of inhaled corticosteroids (ICSs) or various combinations for optimal control. EPR3 recommends considering step down in therapy if patient is well controlled for 3 consecutive months, which may lead to discontinuation of daily medications for patients receiving low dose ICSs or other controller monotherapy. In addition, patients and parents have a tendency to stop the daily medications after having a period of controlled asthma. In these situations, the challenge is to find the best way to discontinue daily medications in patients with mild or intermittent asthma whose daily or weekly impairment is under good control but may still be at risk for asthma exacerbations. The question is, “May another regimen other than daily use of ICSs be used in these patients who become asymptomatic with appropriate treatment to decrease the risk of asthma exacerbation?”
- Published
- 2011
37. Principles of Pharmacotherapeutics
- Author
-
Hengameh H. Raissy and H. William Kelly
- Subjects
business.industry ,Medicine ,business - Published
- 2014
38. Small Airway Targeted Therapy in Pediatric Asthma: Are We There Yet?
- Author
-
Hengameh H. Raissy and Kathryn V. Blake
- Subjects
Pulmonary and Respiratory Medicine ,Pediatrics ,medicine.medical_specialty ,business.industry ,Small airways ,medicine.medical_treatment ,respiratory system ,medicine.disease ,Asthma management ,Targeted therapy ,respiratory tract diseases ,Clinical trial ,Pharmacotherapy Update ,immune system diseases ,Pediatrics, Perinatology and Child Health ,Immunology and Allergy ,Medicine ,business ,Airway ,Intensive care medicine ,Standard therapy ,Pediatric asthma ,Asthma - Abstract
Asthma is characterized by inflammation of proximal and distal airways. As new formulations of extrafine aerosol particles have become available, targeting small airways for the management of asthma has been investigated. As new studies attempt to explore the correlation between small airway dysfunction and clinical outcomes in asthma, well-designed clinical trials are needed to compare targeted and standard therapy for asthma management especially in pediatric patients.
- Published
- 2013
39. PURLs: This asthma treatment has a lasting side effect in children
- Author
-
Paul D. Williams, Hengameh H. Raissy, H. William Kelly, Anne L. Fuhlbrigge, Alice L. Sternberg, Rachel Lescher, Robert S. Zeiger, James Tonascia, Mark L. Van Natta, and Robert C. Strunk
- Subjects
Budesonide ,Nedocromil ,Adult ,Male ,Pediatrics ,medicine.medical_specialty ,Adolescent ,Growth ,Placebo ,PURLs® ,Article ,law.invention ,Randomized controlled trial ,law ,Administration, Inhalation ,medicine ,Humans ,Anti-Asthmatic Agents ,Child ,Glucocorticoids ,Asthma ,Intention-to-treat analysis ,business.industry ,General Medicine ,medicine.disease ,Confidence interval ,Body Height ,respiratory tract diseases ,Intention to Treat Analysis ,Child, Preschool ,Female ,business ,Glucocorticoid ,medicine.drug ,Follow-Up Studies - Abstract
The use of inhaled glucocorticoids for persistent asthma causes a temporary reduction in growth velocity in prepubertal children. The resulting decrease in attained height 1 to 4 years after the initiation of inhaled glucocorticoids is thought not to decrease attained adult height.We measured adult height in 943 of 1041 participants (90.6%) in the Childhood Asthma Management Program; adult height was determined at a mean (±SD) age of 24.9±2.7 years. Starting at the age of 5 to 13 years, the participants had been randomly assigned to receive 400 μg of budesonide, 16 mg of nedocromil, or placebo daily for 4 to 6 years. We calculated differences in adult height for each active treatment group, as compared with placebo, using multiple linear regression with adjustment for demographic characteristics, asthma features, and height at trial entry.Mean adult height was 1.2 cm lower (95% confidence interval [CI], -1.9 to -0.5) in the budesonide group than in the placebo group (P=0.001) and was 0.2 cm lower (95% CI, -0.9 to 0.5) in the nedocromil group than in the placebo group (P=0.61). A larger daily dose of inhaled glucocorticoid in the first 2 years was associated with a lower adult height (-0.1 cm for each microgram per kilogram of body weight) (P=0.007). The reduction in adult height in the budesonide group as compared with the placebo group was similar to that seen after 2 years of treatment (-1.3 cm; 95% CI, -1.7 to -0.9). During the first 2 years, decreased growth velocity in the budesonide group occurred primarily in prepubertal participants.The initial decrease in attained height associated with the use of inhaled glucocorticoids in prepubertal children persisted as a reduction in adult height, although the decrease was not progressive or cumulative. (Funded by the National Heart, Lung, and Blood Institute and the National Center for Research Resources; CAMP ClinicalTrials.gov number, NCT00000575.).
- Published
- 2013
40. Inhaled corticosteroids in lung diseases
- Author
-
Stanley J. Szefler, Hengameh H. Raissy, Michelle Harkins, and H. William Kelly
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Pulmonary Perspective ,Cost-Benefit Analysis ,Anti-Inflammatory Agents ,Disease ,Pharmacology ,Critical Care and Intensive Care Medicine ,Pulmonary Disease, Chronic Obstructive ,Therapeutic index ,Quality of life ,Adrenal Cortex Hormones ,Internal medicine ,Administration, Inhalation ,medicine ,Humans ,Adverse effect ,Asthma ,COPD ,Lung ,Inhalation ,business.industry ,medicine.disease ,respiratory tract diseases ,medicine.anatomical_structure ,Disease Progression ,business ,Immunosuppressive Agents - Abstract
Inhaled corticosteroids (ICSs) are used extensively in the treatment of asthma and chronic obstructive pulmonary disease (COPD) due to their broad antiinflammatory effects. They improve lung function, symptoms, and quality of life and reduce exacerbations in both conditions but do not alter the progression of disease. They decrease mortality in asthma but not COPD. The available ICSs vary in their therapeutic index and potency. Although ICSs are used in all age groups, younger and smaller children may be at a greater risk for adverse systemic effects because they can receive higher mg/kg doses of ICSs compared with older children. Most of the benefit from ICSs occurs in the low to medium dose range. Minimal additional improvement is seen with higher doses, although some patients may benefit from higher doses. Although ICSs are the preferred agents for managing persistent asthma in all ages, their benefit in COPD is more controversial. When used appropriately, ICSs have few adverse events at low to medium doses, but risk increases with high-dose ICSs. Although several new drugs are being developed and evaluated, it is unlikely that any of these new medications will replace ICSs as the preferred initial long-term controller therapy for asthma, but more effective initial controller therapy could be developed for COPD.
- Published
- 2013
41. MDI versus Nebulizers for Acute Asthma
- Author
-
Hengameh H. Raissy and H. William Kelly
- Subjects
medicine.medical_specialty ,business.industry ,MEDLINE ,Emergency department ,Cochrane Library ,medicine.disease ,Metered-dose inhaler ,law.invention ,Nebulizer ,Randomized controlled trial ,law ,Relative risk ,Pediatrics, Perinatology and Child Health ,medicine ,Pharmacology (medical) ,Intensive care medicine ,business ,Review Articles ,Asthma - Abstract
OBJECTIVE: To evaluate studies comparing metered dose inhalers with holding chambers to nebulizers in the emergency department for the treatment of asthma exacerbation. DATA SOURCE: Primary articles and systematic review provided by the Cochrane Airways Review Group of the Cochrane Library identified by MEDLINE search (1966–February 2004) and through secondary sources. DATA SYNTHESIS: The Cochrane review included 21 randomized clinical trials conducted in hospital emergency departments comparing clinical outcomes following β2 agonist administration via a nebulizer or a metered dose inhaler with holding chamber. Although the relative risk ratio of hospital admission with metered dose inhaler and holding chamber did not differ in children or in adults compared to the nebulizer delivery, none of the individual studies reviewed were powered to detect a difference in the rate of hospital admission. Specific factors in the treatment of acute asthma such as assessment of severity, appropriate outcome selection, appropriate dose selection, and appropriate delivery systems need to be considered to critically evaluate the literature. CONCLUSION: Although available randomized clinical trials suggest equivalency of metered dose inhaler plus holding chambers and nebulized delivery of inhaled β2 agonists, these trials are biased to show no difference in response. There is no data to support the advantage of one method over the other in mild to moderate asthmatic patients either clinically or economically.
- Published
- 2012
42. Reply
- Author
-
James F. Chmiel, Heber C. Nielsen, Hengameh H. Raissy, Anne M. Fitzpatrick, Wanda Phipatanakul, George P. Giacoia, Thomas P. Green, Daniel J. Jackson, and Stanley J. Szefler
- Subjects
Information retrieval ,Text mining ,business.industry ,Immunology ,Immunology and Allergy ,Medicine ,business - Published
- 2014
43. Orthostatic proteinuria and the spectrum of diurnal variability of urinary protein excretion in healthy children
- Author
-
Hengameh H. Raissy, John R. Brandt, Ellen Kaufman, Amy Staples, Franceska Marie Kelly, Craig S. Wong, and Aaron Jacobs
- Subjects
Male ,medicine.medical_specialty ,Supine position ,Adolescent ,Posture ,Urology ,Renal function ,Urinalysis ,Article ,Excretion ,chemistry.chemical_compound ,Orthostatic vital signs ,Young Adult ,Internal medicine ,medicine ,Humans ,Child ,Morning ,Creatinine ,Proteinuria ,business.industry ,Endocrinology ,chemistry ,Nephrology ,Pediatrics, Perinatology and Child Health ,Female ,medicine.symptom ,business ,Body mass index - Abstract
The aim of this study was to characterize the 24-h and diurnal variability of urinary protein excretion and identify the prevalence of orthostatic proteinuria (OP) in healthy children. Upright, supine, and 24-h total urinary protein (UrTP) and creatinine clearance (CrCl) were measured in 91 healthy children ages 6–19 years. Urinary protein and creatinine excretions were calculated and examined by gender, age, Tanner stage, and body mass index (BMI). Orthostatic proteinuria (OP) was defined as a 24-h UrTP >100 mg/m2 with a normal supine UrTP (10 years and BMI >85%. In children with OP, a first morning UPcr shows a value in the normal range, whereas a random daytime UPcr is elevated. There exists a diurnal variability in urinary protein excretion that is exaggerated in participants with OP. UPcr reliably estimates 24-h UrTP. Using current pediatric criteria, OP is very common, particularly in boys. A normal first morning UPcr ratio indicates that a child with elevated random urinary protein has OP.
- Published
- 2010
44. Long-term effect of budesonide on hypothalamic-pituitary-adrenal axis function in children with mild to moderate asthma
- Author
-
Bennie McWilliams, Laura A. Wilson, Hengameh H. Raissy, Robert C. Strunk, H. William Kelly, and Leonard B. Bacharier
- Subjects
Budesonide ,Nedocromil ,Male ,endocrine system ,medicine.medical_specialty ,Hypothalamo-Hypophyseal System ,Hydrocortisone ,medicine.drug_class ,Pituitary-Adrenal System ,Placebo ,Adrenocorticotropic Hormone ,Internal medicine ,Administration, Inhalation ,medicine ,Humans ,Child ,Glucocorticoids ,Asthma ,business.industry ,Nebulizers and Vaporizers ,medicine.disease ,Bronchodilator Agents ,Endocrinology ,medicine.anatomical_structure ,Child, Preschool ,Pediatrics, Perinatology and Child Health ,Corticosteroid ,Prednisone ,Female ,business ,hormones, hormone substitutes, and hormone antagonists ,Glucocorticoid ,Hypothalamic–pituitary–adrenal axis ,medicine.drug ,Follow-Up Studies - Abstract
Objective. To determine the safety of long-term (36 months) administration of an inhaled corticosteroid (budesonide) on hypothalamic-pituitary-adrenal (HPA) axis function in children with mild to moderate asthma.Methods. This was an ancillary study of the Childhood Asthma Management Program (CAMP). Sixty-three children who had mild to moderate asthma and were enrolled in CAMP underwent evaluation of HPA axis function before and 12 and 36 months after receiving continuous therapy with either an inhaled anti-inflammatory agent (budesonide 400 μg/day or nedocromil 16 mg/day) or placebo. HPA axis function was assessed by serum cortisol levels 30 and 60 minutes after 0.25 mg of adrenocorticotrophic hormone (ACTH) and 24-hour urinary free cortisol excretion.Results. There were no differences in serum cortisol levels after ACTH stimulation between treatment groups, regardless of time after ACTH administration or months of follow-up. Urinary cortisol excretion per body surface area was similar in both treatment groups at 36 months, after adjusting for age at randomization, race, gender, and clinic. Cumulative inhaled corticosteroid exposure did not influence serum cortisol response to ACTH or urinary free cortisol excretion at 36 months.Conclusions. We found no effects of chronic budesonide treatment at a dose of 400 μg/day on HPA axis function in children with mild to moderate asthma and demonstrated the absence of a cumulative effect on HPA axis function over a 3-year period.
- Published
- 2004
45. Inhalatiesteroïden hebben een blijvend effect op lengtegroei bij kinderen met astma
- Author
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R.C. Strunk, Paul D. Williams, Anne L. Fuhlbrigge, ML Van Natta, Hengameh H. Raissy, Kelly Hw, Rachel Lescher, Robert S. Zeiger, Alice L. Sternberg, and J Tonascia
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Gynecology ,medicine.medical_specialty ,business.industry ,Pediatrics, Perinatology and Child Health ,medicine ,business - Published
- 2012
46. Management of Wheezing in Preschool Children
- Author
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Hengameh H. Raissy and Kathryn V. Blake
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Pulmonary and Respiratory Medicine ,Pediatrics ,medicine.medical_specialty ,Growth retardation ,business.industry ,medicine.disease ,Panel report ,Pediatrics, Perinatology and Child Health ,medicine ,Immunology and Allergy ,Controller medication ,business ,Persistent asthma ,Asthma - Abstract
Diagnosis and management of asthma in preschool children are challenging. The Expert Panel Report 3 has recommendations for specific illness phenotypes to start long-term controller medication to reduce risk and impairment in children ages 0–4-year old. The use of daily-inhaled corticosteroids has shown to be effective in preschool children with persistent asthma, but there are also reports of growth retardation. For children with recurrent or intermittent wheezing without symptoms in between episodes, the intermittent use of controller medications may be an option for certain phenotypes. This review will discuss the available data on use of intermittent controller medications in preschool children with wheezing.
- Published
- 2012
47. Project ECHO: Improving Asthma Care in New Mexico With Telehealth Technology
- Author
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Michelle Harkins, Kathleen Moseley, Hengameh H. Raissy, Karen Luttecke, and Sanjeev Arora
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,business.industry ,Echo (computing) ,Telehealth ,Critical Care and Intensive Care Medicine ,Asthma management ,medicine.disease ,Asthma care ,medicine ,Medical emergency ,Cardiology and Cardiovascular Medicine ,Intensive care medicine ,business - Published
- 2011
48. Risk of cataracts in the Childhood Asthma Management Program Cohort
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Alice L. Sternberg, Paul D. Williams, Aaron Jacobs, William Kelly H. William Kelly, and Hengameh H. Raissy
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Adult ,Male ,Budesonide ,Pediatrics ,medicine.medical_specialty ,Immunology ,Population ,Article ,Cataract ,Nedocromil ,Risk Factors ,Prednisone ,Anti-Allergic Agents ,medicine ,Humans ,Immunology and Allergy ,Risk factor ,Child ,education ,Glucocorticoids ,Asthma ,education.field_of_study ,Cumulative dose ,business.industry ,Infant ,Odds ratio ,medicine.disease ,Surgery ,Child, Preschool ,Female ,business ,Follow-Up Studies ,medicine.drug ,Cohort study - Abstract
To the editor: Use of systemic corticosteroids is a well established risk factor for the development of posterior subcapsular cataracts (PSCs) in both children and adults.1 Dose and duration of inhaled corticosteroids (ICSs) have been reported to be independent risk factors for the development of PSCs in older patients.2 Occurrence of PSCs is rare in children, and studies of children treated with ICSs have not found an increased risk of PSCs.3–5 We previously reported no risk of cataracts in 955 children in the Childhood Asthma Management Program (CAMP) assessed by lens photography after 4–6 years (mean 4.3 years) of budesonide 400 µg/day by Turbuhaler™, nedocromil 16 mg/day or placebo. However, one child in the budesonide group was diagnosed as having a barely measurable PSC on slit lamp exam 5 months after the photography.8 The CAMP cohort has been followed continuously since closure of the trial in 1999. In 2005, two additional participants (both from the budesonide arm) reported PSCs, with one requiring surgery. In response to these reports and in consultation with the CAMP Data and Safety Monitoring Board, all CAMP participants were urged to obtain a dilated slit lamp examination specifically for the presence of cataracts (Supplementary Appendices E1 and E2). The findings from the resulting exams plus the 3 reports of cataracts obtained previously form the basis of this report. Three outcomes were defined for each participant: examination for cataract, any cataract finding, and any posterior finding. Covariates included cumulative doses of ICSs and oral corticosteroid for asthma to the date of the cataract exam. The ICSs included the blinded budesonide and unblinded ICSs prescribed during the trial and ICS self-reported as taken for asthma during the observational post-trial follow-up. Prednisone bursts during the post trial follow-up were assumed to conform to the CAMP trial regimen (up to 60 mg for each of 2 days, followed by up to 30 mg for each of 2 days). The association of each outcome with randomized treatment group and with inhaled and oral corticosteroid use for asthma categorized as ever versus never was assessed by chi square analysis and logistic regression. Association of cataract posterior finding with the cumulative dose of ICS and cumulative dose of oral corticosteroid was assessed by logistic regression. Each cumulative dose was modeled first as a continuous variable and then as three indicator variables corresponding to tertiles of increasing dose. Lastly, each cumulative dose was modeled as a score based on the tertiles as a test for a dose-response effect. Analyses were performed using SAS 9.1 (SAS Institute Inc., Cary, NC) or STATA 9.2 (StataCorp, College Station, TX). 232 participants aged 15 to 26 years were examined, 22.3% of the original CAMP cohort (N=1041). Median duration from randomization to exam was 12 years (range 4–14 years), and median duration from lens photography to exam was 8 years (range 0.4–9 years). Median duration of ICS use among those using ICSs was 4.0 years (range 0–13) and median 4-day dose (per burst) of prednisone during CAMP, for those ever taking prednisone for asthma during CAMP, was 150 mg range (15–180). Sixteen participants were assessed as having cataract findings, of whom 12 were classified as having posterior findings (Table E1). The percentage of participants obtaining exams was similar across randomized treatment groups (22.8% budesonide, 22.1% nedocromil, 22.0% placebo, P=0.96: Table 1, Panel A). Among those examined, there was no evidence of increased cataracts in the budesonide compared to the placebo group (odds ratio (OR) = 1.6, 95% CI=(0.5, 4,9), P=0.44), nor any evidence of increased posterior findings (OR=1.3, 95% CI=(0.4, 4.7), P=0.67) (Table 1, Panel A). Table 1 Examination for cataracts and cataract findings by randomized treatment and ever versus never use of corticosteroids for asthma Participants ever using corticosteroids for asthma were more likely to obtain a cataract exam (25.8% ever using ICS versus 12.8% never using ICS, P 10 mg/day); duration (> 2 years); and method of administration (daily versus every other day). It is possible that some children with multiple courses of oral prednisone per year developed PSCs that then regressed, as this has been previously reported.9 We report a 5.2% prevalence of posterior findings in our participants which is much higher than the 0.2% in healthy young adults quoted from population based studies.1,2 However, these studies used reports of clinically significant cataracts. In that regard, our finding of one patient requiring surgery for cataract is not significantly different from that reported in the NHANES 2007–2008 vision questionnaire database for participants 14–25 years old (1/232 versus 2/1621, p=0.33 Fisher’s exact test).10 Our high prevalence could be a consequence of our specific request that the eye care provider to look for cataracts. Additionally the finding of more cataracts on slit-lamp exam than on lens photography was recently reported.11 A weakness of our report is that only 22.3% of the CAMP population obtained a dilated slit lamp examination; our power to detect a difference in risk is very low, as indicated by the broad 95% confidence limits on our risk estimates. Nevertheless, ours is one of the largest studies in children with asthma to date, and despite those who had greater corticosteroid exposure being more likely to have obtained an exam, we did not find any association between cataract findings and exposure to corticosteroids for asthma (Tables1 and and2).2). Another weakness was lack of standardization in the ophthalmic exam and the prompt to eye care providers to look specifically for evidence of cataracts. However, this represents what happens in the real world outside of standardized clinical trials. Additionally, our dose data are a mix of prescribed dose (during the trial) and reported dose taken (during the follow-up phases). Finally, we did not include use of nasal and topical corticosteroids in the analysis, nor use of corticosteroids for conditions other than asthma. However, in a population based case-control study, exposure to topical corticosteroids did not affect the association between cataract and use of inhaled corticosteroids.2 Our findings of a lack of cumulative effect of ICSs and short bursts of oral corticosteroids does not rule out the possibility that high daily doses of ICSs will contribute to cataract formation, particularly in patients with other risk factors.3–5 In conclusion, the long-term use of ICSs in the recommended ranges in combination with occasional bursts of oral prednisone during childhood was not associated with an increased risk of cataracts. Thus, regular monitoring for cataracts does not appear to be warranted in children, adolescents and young adults with asthma being treated with low-medium dose ICS without other significant risk factors.
- Published
- 2010
49. Daily or intermittent budesonide in preschool children with recurrent wheezing
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Theresa W. Guilbert, Noah J. Friedman, Susan J. Boehmer, David T. Mauger, Stanley J. Szefler, Daniel J. Jackson, Leonard B. Bacharier, Christine A. Sorkness, Robert S. Zeiger, Fernando D. Martinez, Ronina A. Covar, Michael Mellon, Michael Schatz, Vernon M. Chinchilli, Hengameh H. Raissy, H. William Kelly, Robert F. Lemanske, James E. Gern, Wayne J. Morgan, Jonathan Malka-Rais, Elizabeth Bade, Robert C. Strunk, Lynn M. Taussig, and Avraham Beigelman
- Subjects
Budesonide ,Male ,Pediatrics ,medicine.medical_specialty ,Exacerbation ,Prednisolone ,Administration, Oral ,Severity of Illness Index ,Drug Administration Schedule ,law.invention ,Randomized controlled trial ,law ,Severity of illness ,Administration, Inhalation ,medicine ,Humans ,Respiratory sounds ,Treatment Failure ,Glucocorticoids ,Asthma ,Respiratory Sounds ,medicine.diagnostic_test ,business.industry ,Infant ,General Medicine ,medicine.disease ,Bronchodilator Agents ,Regimen ,Child, Preschool ,Female ,business ,medicine.drug - Abstract
Daily inhaled glucocorticoids are recommended for young children at risk for asthma exacerbations, as indicated by a positive value on the modified asthma predictive index (API) and an exacerbation in the preceding year, but concern remains about daily adherence and effects on growth. We compared daily therapy with intermittent therapy.We studied 278 children between the ages of 12 and 53 months who had positive values on the modified API, recurrent wheezing episodes, and at least one exacerbation in the previous year but a low degree of impairment. Children were randomly assigned to receive a budesonide inhalation suspension for 1 year as either an intermittent high-dose regimen (1 mg twice daily for 7 days, starting early during a predefined respiratory tract illness) or a daily low-dose regimen (0.5 mg nightly) with corresponding placebos. The primary outcome was the frequency of exacerbations requiring oral glucocorticoid therapy.The daily regimen of budesonide did not differ significantly from the intermittent regimen with respect to the frequency of exacerbations, with a rate per patient-year for the daily regimen of 0.97 (95% confidence interval [CI], 0.76 to 1.22) versus a rate of 0.95 (95% CI, 0.75 to 1.20) for the intermittent regimen (relative rate in the intermittent-regimen group, 0.99; 95% CI, 0.71 to 1.35; P=0.60). There were also no significant between-group differences in several other measures of asthma severity, including the time to the first exacerbation, or adverse events. The mean exposure to budesonide was 104 mg less with the intermittent regimen than with the daily regimen.A daily low-dose regimen of budesonide was not superior to an intermittent high-dose regimen in reducing asthma exacerbations. Daily administration led to greater exposure to the drug at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; MIST ClinicalTrials.gov number, NCT00675584.).
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