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1. Benefit of switching to mepolizumab from omalizumab in severe eosinophilic asthma based on patient characteristics

Author

Mark C. Liu, Bradley Chipps, Xavier Munoz, Gilles Devouassoux, Miguel Bergna, Steven G. Smith, Robert G. Price, Dmitry V. Galkin, Jay Azmi, Dalal Mouneimne, Frank C. Albers, and Kenneth R. Chapman

Subjects
Asthma, Asthma treatment, Biologics, Eosinophils, Diseases of the respiratory system, RC705-779
Abstract

Abstract Background The OSMO study assessed the efficacy of switching to mepolizumab in patients with severe eosinophilic asthma that was uncontrolled whilst receiving omalizumab. The objective of this analysis was to assess the proportion of patients achieving pre-defined improvements in up to four efficacy outcomes and the relationship between patient baseline characteristics and treatment response. Methods This was a post hoc analysis of OSMO study data (GSK ID:204471; ClinicalTrials.gov No. NCT02654145). Patients with severe eosinophilic asthma uncontrolled by high-dose inhaled corticosteroids, other controller(s) and omalizumab subcutaneously (≥ 4 months) were switched to mepolizumab 100 mg administered subcutaneously. Endpoints included the proportion of responders—i.e. patients achieving a pre-defined clinical improvement in ≥ 1 of the following outcomes: (1) Asthma Control Questionnaire (ACQ)-5 score (≥ 0.5-points), (2) St George’s Respiratory Questionnaire (SGRQ) total score (≥ 4-points), (3) pre-bronchodilator forced expiratory volume in 1s (FEV1; ≥ 100 mL), all at Week 32, and (4) annualised rate of clinically significant exacerbations (≥ 50% reduction). Results Of the 145 patients included, 94%, 83%, 63% and 31% were responders for ≥ 1, ≥ 2, ≥ 3 and 4 outcomes, respectively; 75% and 78% were ACQ-5 and SGRQ score responders, and 50% and 69% were FEV1 and exacerbation responders. Subgroup analyses demonstrated improvements irrespective of baseline blood eosinophil count, prior omalizumab treatment regimen/duration, comorbidities, prior exacerbation history, maintenance oral corticosteroid use, ACQ-5 and SGRQ scores, and body weight/body mass index. Conclusions After switching to mepolizumab, almost all patients with uncontrolled severe eosinophilic asthma on omalizumab achieved a beneficial response in ≥ 1 clinical outcome. Improvements were observed regardless of baseline characteristics. Trial registration This manuscript is a post hoc analysis of data from the OSMO study. ClinicalTrials.gov, NCT02654145. Registered January 13, 2016.

Published
2021
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7. Review of efficacy of ciclesonide for the treatment of asthma in children

Author

Michael Blaiss, William Berger, Bradley Chipps, Vivian Hernandez-Trujillo, Wanda Phipatanakul, and Keith Steward

Subjects
Pulmonary and Respiratory Medicine, General Medicine, Articles, Asthma, respiratory tract diseases, Bronchodilator Agents, Treatment Outcome, Clinical Trials, Phase III as Topic, Double-Blind Method, Adrenal Cortex Hormones, Pregnenediones, Forced Expiratory Volume, Administration, Inhalation, Immunology and Allergy, Fluticasone, Humans, Budesonide, Child, Randomized Controlled Trials as Topic
Abstract

Background: Ciclesonide (CIC) is an inhaled corticosteroid (ICS) approved for the maintenance treatment of asthma in patients ages ≥ 12 years. The prodrug aspect of CIC is associated with a safety profile that may make it ideal for children. Objective: The objective was to summarize efficacy results from the eight phase III, randomized, double-blind, controlled trials in children with asthma conducted during CIC clinical development. Methods: Four trials compared CIC 40, 80, or 160 µg/day with placebo. Two trials compared CIC 160 µg/day with fluticasone propionate 200 µg/day, one trial compared CIC 80 or 160 µg/day with fluticasone 200 µg/day, and one trial compared CIC 160 µg/day with budesonide 400 µg/day. Results: The primary end point was met by at least two CIC doses versus placebo in the trials in which the primary end point was the change from baseline in lung function outcome (forced expiratory volume in 1 second [FEV1] % predicted or morning peak expiratory flow [PEF]). A trial that compared CIC with placebo did not meet the primary end point of superiority in time-to-first severe wheeze exacerbation or lack of improvement. The primary end point of noninferiority to the active control (fluticasone or budesonide) in the change from baseline in a lung function outcome (FEV1, morning PEF, evening PEF) was met with the CIC 160-µg dose in all active control trials. CIC generally demonstrated statistically significant improvements in forced expiratory flow at 25%‐75% of forced vital capacity, asthma symptoms, rescue medication use, and asthma control when compared with placebo and noninferiority for these outcomes compared with fluticasone or budesonide. Conclusion: In children with asthma, once-daily CIC significantly improved large and small airway function, asthma symptoms, and asthma control, and reduced rescue medication use compared with placebo. CIC was comparable with other ICS used to treat asthma in children, which demonstrated its worth for the pediatric population.

Published
2021

8. The Asthma Impairment and Risk Questionnaire (AIRQ) Control Level Predicts Future Risk of Asthma Exacerbations

Author

David A. Beuther, Kevin R. Murphy, Robert S. Zeiger, Robert A. Wise, William McCann, Joan Reibman, Maureen George, Ileen Gilbert, James M. Eudicone, Hitesh N. Gandhi, Melissa Ross, Karin S. Coyne, and Bradley Chipps

Subjects
Immunology and Allergy
Abstract

The Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item, equally weighted, yes/no control tool validated in patients with asthma aged 12 years and older.To evaluate AIRQ's ability to predict patient-reported exacerbations over 12 months.Patients completed a baseline AIRQ during an in-person enrollment visit and reported exacerbations (ie, asthma-related courses of oral corticosteroids, emergency department/urgent care visits, and hospitalizations) via monthly online surveys. Logistic regressions were performed using AIRQ control level (well-controlled [WC], not well-controlled [NWC], very poorly controlled [VPC]), age, sex, race, and body mass index as covariates and 1 or more and 2 or more exacerbations as the dependent variables (adjusted odds ratios [OR] and 95% Wald CIs). Kaplan-Meier analyses of time to first exacerbation by AIRQ control level were performed.A total of 1,112 patients were enrolled; 1,070 completed 1 or more surveys over 12 months (mean ± SD 10.5 ± 2.8 months); 70.5% female; age 43.9 ± 19.3 years; 20.4% non-White; body mass index 30.6 ± 8.7 kg/mThe AIRQ control level predicts exacerbation risk over 12 months and probability of time to first exacerbation.

Published
2022
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10. The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma

Author

Dmitry V Galkin, Bradley Chipps, Miguel Bergna, Dalal Mouneimne, Mark C. Liu, Frank C. Albers, Xavier Muñoz, Gilles Devouassoux, Jay Azmi, Kenneth R. Chapman, and Robert Price

Subjects
Male, 0301 basic medicine, Exacerbation, Eosinophilic asthma, Omalizumab, Severity of Illness Index, ACQ‐5, Leukocyte Count, 0302 clinical medicine, Surveys and Questionnaires, Immunology and Allergy, Medicine, Anti-Asthmatic Agents, Child, education.field_of_study, Drug Substitution, mepolizumab, Middle Aged, 3. Good health, Treatment Outcome, Tolerability, Asthma Control Questionnaire, Female, Original Article, medicine.drug, Adult, medicine.medical_specialty, Adolescent, Immunology, Population, Antibodies, Monoclonal, Humanized, Asthma and Lower Airway Disease, Young Adult, 03 medical and health sciences, Internal medicine, Humans, education, Aged, business.industry, Asthma, severe eosinophilic asthma, asthma control, Eosinophils, 030104 developmental biology, Standard error, 030228 respiratory system, Quality of Life, ORIGINAL ARTICLES, business, Mepolizumab
Abstract

Background Mepolizumab and omalizumab are treatments for distinct but overlapping severe asthma phenotypes. Objective To assess if patients eligible for both biologics but not optimally controlled with omalizumab experience improved asthma control when switched directly to mepolizumab. Methods OSMO was a multicenter, open‐label, single‐arm, 32‐week trial in patients with ≥2 asthma exacerbations in the year prior to enrollment, despite receiving high‐dose inhaled corticosteroids and other controller(s), plus omalizumab (≥4 months). At baseline, patients with blood eosinophil counts ≥150 cells/µL (or ≥300 cells/µL in the prior year) and an Asthma Control Questionnaire (ACQ)‐5 score ≥1.5 discontinued omalizumab and immediately commenced mepolizumab 100 mg subcutaneously every 4 weeks. Endpoints included change from baseline in ACQ‐5 score (primary), St George's Respiratory Questionnaire (SGRQ) score and the proportions of ACQ‐5 and SGRQ responders, all at Week 32, and the annualized exacerbation rate over the study period. Results At Week 32 (intent‐to‐treat population [n = 145]), the least squares (LS) mean changes (standard error [SE]) in ACQ‐5 and SGRQ total scores were −1.45 (0.107) and −19.0 (1.64) points; with 77% and 79% of patients achieving the minimum clinically important differences (ACQ‐5: ≥0.5 points; SGRQ: ≥4 points), respectively. The annualized rate of clinically significant exacerbations was 1.18 events/year, a 64% reduction from 3.26 events/year during the previous year. Safety and immunogenicity profiles were consistent with previous trials. Conclusion After directly switching from omalizumab to mepolizumab, patients with uncontrolled severe eosinophilic asthma experienced clinically significant improvements in asthma control, health status, and exacerbation rate, with no tolerability issues reported., Minimal clinically important difference for improvement in asthma control questionnaire‐5 and St. George's Respiratory Questionnaire total scores was achieved by 77% and 79% of patients, respectively. Annualized rate of clinically significant exacerbations was reduced from 3.26 to 1.18 events/year. Safety and immunogenicity profiles of mepolizumab were consistent with previous placebo‐controlled trials in severe eosinophilic asthma.

Published
2019
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11. The burden of mild asthma: Clinical burden and healthcare resource utilisation in the NOVELTY study

Author

Sarowar Muhammad Golam, Christer Janson, Richard Beasley, J Mark FitzGerald, Tim Harrison, Bradley Chipps, Rod Hughes, Hana Müllerová, José María Olaguibel, Eleni Rapsomaniki, Helen K. Reddel, Mohsen Sadatsafavi, Gabriel Benhabib, Piushkumar Mandhane, Xavier Bocca Ruiz, Andrew McIvor, Ricardo del Olmo, Bonavuth Pek, Raul Eduardo Lisanti, Robert Petrella, Gustavo Marino, Daniel Stollery, Walter Mattarucco, Meihua Chen, Juan Nogueira, Yan Chen, Maria Parody, Wei Gu, Pablo Pascale, Kim Ming Christopher Hui, Pablo Rodriguez, Manxiang Li, Damian Silva, Shiyue Li, Graciela Svetliza, Lijun Ma, Carlos F. Victorio, Guangyue Qin, Roxana Willigs Rolon, Weidong Song, Anahi Yañez, Wei Tan, Stuart Baines, Yijun Tang, Simon Bowler, Chen Wang, Peter Bremner, Tan Wang, Sheetal Bull, Fuqiang Wen, Patrick Carroll, Feng Wu, Mariam Chaalan, PingChao Xiang, Claude Farah, Zuke Xiao, Gary Hammerschlag, Shengdao Xiong, Kerry Hancock, Jinghua Yang, Zinta Harrington, Jingping Yang, Gregory Katsoulotos, Caiqing Zhang, Joshua Kim, Min Zhang, David Langton, Ping Zhang, Donald Lee, Wei Zhang, Matthew Peters, Xiaohe Zheng, Lakshman Prassad, Dan Zhu, Helen Reddel, Fabio Bolivar Grimaldos, Dimitar Sajkov, Alejandra Cañas Arboleda, Francis Santiago, Carlos Matiz Bueno, Frederick Graham Simpson, Dora Molina de Salazar, Sze Tai, Elisabeth Bendstrup, Paul Thomas, Ole Hilberg, Peter Wark, Carsten Kjellerup, José Eduardo Delfini Cançado, Ulla Weinreich, Thúlio Cunha, Philippe Bonniaud, Marina Lima, Olivier Brun, Alexandre Pinto Cardoso, Pierre-Régis Burgel, Marcelo Rabahi, Christos Chouaid, Syed Anees, Francis Couturaud, John Bertley, Jacques de Blic, Alan Bell, Didier Debieuvre, Amarjit Cheema, Dominique Delsart, Guy Chouinard, Axelle Demaegdt, Michael Csanadi, Pascal Demoly, Anil Dhar, Antoine Deschildre, Ripple Dhillon, Gilles Devouassoux, J. Mark FitzGerald, Carole Egron, David Kanawaty, Lionel Falchero, Allan Kelly, François Goupil, William Killorn, Romain Kessler, Daniel Landry, Pascal Le Roux, Robert Luton, Pascal Mabire, Guillaume Mahay, Yumiko Ide, Stéphanie Martinez, Minehiko Inomata, Boris Melloni, Hiromasa Inoue, Laurent Moreau, Koji Inoue, Chantal Raherison, Sumito Inoue, Emilie Riviere, Motokazu Kato, Pauline Roux-Claudé, Masayuki Kawasaki, Michel Soulier, Tomotaka Kawayama, Guillaume Vignal, Toshiyuki Kita, Azzedine Yaici, Kanako Kobayashi, Sven Philip Aries, Hiroshi Koto, Robert Bals, Koichi Nishi, Ekkehard Beck, Junpei Saito, Andreas Deimling, Yasuo Shimizu, Jan Feimer, Toshihiro Shirai, Vera Grimm-Sachs, Naruhiko Sugihara, Gesine Groth, Ken-ichi Takahashi, Felix Herth, Hiroyuki Tashimo, Gerhard Hoheisel, Keisuke Tomii, Frank Kanniess, Takashi Yamada, Thomas Lienert, Masaru Yanai, Silke Mronga, Ruth Cerino Javier, Jörg Reinhardt, Alfredo Domínguez Peregrina, Christian Schlenska, Marco Fernández Corzo, Christoph Stolpe, Efraín Montano Gonzalez, Ishak Teber, Alejandra Ramírez-Venegas, Hartmut Timmermann, Adrian Rendon, Thomas Ulrich, Willem Boersma, Peter Velling, R.S. Djamin, Sabina Wehgartner-Winkler, Michiel Eijsvogel, Juergen Welling, Frits Franssen, Ernst-Joachim Winkelmann, Martijn Goosens, Carlo Barbetta, Lidwien Graat-Verboom, Fulvio Braido, Johannes in 't Veen, Vittorio Cardaci, Rob Janssen, Enrico Maria Clini, Kim Kuppens, Maria Teresa Costantino, Maarten van den Berge, Giuseppina Cuttitta, Mario van de Ven, Mario di Gioacchino, Ole Petter Brunstad, Alessandro Fois, Gunnar Einvik, Maria Pia Foschino-Barbaro, Kristian Jong Høines, Enrico Gammeri, Alamdar Khusrawi, Riccardo Inchingolo, Torbjorn Oien, Federico Lavorini, Yoon-Seok Chang, Antonio Molino, Young Joo Cho, Eleonora Nucera, Yong Il Hwang, Alberto Papi, Woo Jin Kim, Vincenzo Patella, Young-Il Koh, Alberto Pesci, Byung-Jae Lee, Fabio Ricciardolo, Kwan-Ho Lee, Paola Rogliani, Sang-Pyo Lee, Riccardo Sarzani, Yong Chul Lee, Carlo Vancheri, Seong Yong Lim, Rigoletta Vincenti, Kyung Hun Min, Takeo Endo, Yeon-Mok Oh, Masaki Fujita, Choon-Sik Park, Yu Hara, Hae-Sim Park, Takahiko Horiguchi, Heung-Woo Park, Keita Hosoi, Chin Kook Rhee, Ho Joo Yoon, Alyn Morice, Hyoung-Kyu Yoon, Preeti Pandya, Alvar Agusti García-Navarro, Manish Patel, Rubén Andújar, Kay Roy, Laura Anoro, Ramamurthy Sathyamurthy, María Buendía García, Swaminathan Thiagarajan, Paloma Campo Mozo, Alice Turner, Sergio Campos, Jorgen Vestbo, Francisco Casas Maldonado, Wisia Wedzicha, Manuel Castilla Martínez, Tom Wilkinson, Carolina Cisneros Serrano, Pete Wilson, Lorena Comeche Casanova, Lo’Ay Al-Asadi, Dolores Corbacho, James Anholm, Felix Del Campo Matías, Frank Averill, Jose Echave-Sustaeta, Sandeep Bansal, Gloria Francisco Corral, Alan Baptist, Pedro Gamboa Setién, Colin Campbell, Marta García Clemente, Michael A. Campos, Ignacio García Núñez, Jose García Robaina, Gretchen Crook, Mercedes García Salmones, Samuel DeLeon, Jose Maria Marín Trigo, Alain Eid, Marta Nuñez Fernandez, Ellen Epstein, Sara Nuñez Palomo, Stephen Fritz, José Olaguibel Rivera, Hoadley Harris, Luis Pérez de Llano, Mitzie Hewitt, Ana Pueyo Bastida, Fernando Holguin, Ana Rañó, Golda Hudes, José Rodríguez González-Moro, Richard Jackson, Albert Roger Reig, Alan Kaufman, José Velasco Garrido, David Kaufman, Dan Curiac, Ari Klapholz, Harshavardhan Krishna, Cornelia Lif-Tiberg, Daria Lee, Anders Luts, Robert Lin, Lennart Råhlen, Diego Maselli-Caceres, Stefan Rustscheff, Vinay Mehta, Frances Adams, James N. Moy, Drew Bradman, Ugo Nwokoro, Emma Broughton, Purvi Parikh, John Cosgrove, Sudhir Parikh, Patrick Flood-Page, Frank Perrino, Elizabeth Fuller, James Ruhlmann, Timothy Harrison, Catherine Sassoon, David Hartley, Russell A. Settipane, Keith Hattotuwa, Daniel Sousa, Gareth Jones, Peruvemba Sriram, Keir Lewis, Richard Wachs, Lorcan McGarvey, BioPharmaceuticals R&D [Gothenburg], AstraZeneca, Uppsala University, Malaghan Institute of Medical Research [Wellington, New Zealand], Vancouver Coastal Health Research Institute (VCH), AstraZeneca [Cambridge, UK], Complejo Hospitalario de Navarra, Woolcock Institute of Medical Research [Sydney], The University of Sydney, University of British Columbia (UBC), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Médecine de précision par intégration de données et inférence causale (PREMEDICAL), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Institut Desbrest de santé publique (IDESP), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)

Subjects
Pulmonary and Respiratory Medicine, MESH: Humans, MESH: Asthma, Patient-reported measures, Respiratory Medicine and Allergy, Longitudinal studies, MESH: Patient Acceptance of Health Care, Disease burden, Healthcare resource utilisation, Mild asthma, Patient Acceptance of Health Care, Asthma, MESH: Prospective Studies, MESH: Adrenal Cortex Hormones, Adrenal Cortex Hormones, Disease Progression, Humans, Longitudinal Studies, Prospective Studies, MESH: Disease Progression, MESH: Longitudinal Studies, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Lungmedicin och allergi
Abstract

Background: Patients with mild asthma represent a substantial proportion of the population with asthma, yet there are limited data on their true burden of disease. We aimed to describe the clinical and healthcare resource utilisation (HCRU) burden of physician-assessed mild asthma. Methods: Patients with mild asthma were included from the NOVEL observational longiTudinal studY (NOVELTY; NCT02760329), a global, 3-year, real-world prospective study of patients with asthma and/or chronic obstructive pulmonary disease from community practice (specialised and primary care). Diagnosis and severity were based on physician discretion. Clinical burden included physician-reported exacerbations and patient-reported measures. HCRU included inpatient and outpatient visits. Results: Overall, 2004 patients with mild asthma were included; 22.8% experienced >= 1 exacerbation in the previous 12 months, of whom 72.3% experienced >= 1 severe exacerbation. Of 625 exacerbations reported, 48.0% lasted >1 week, 27.7% were preceded by symptomatic worsening lasting >3 days, and 50.1% required oral corticosteroid treatment. Health status was moderately impacted (St George's Respiratory Questionnaire score: 23.5 [standard deviation +/- 17.9]). At baseline, 29.7% of patients had asthma symptoms that were not well controlled or very poorly controlled (Asthma Control Test score = 2 exacerbations in the previous year. In terms of HCRU, at least one unscheduled ambulatory visit for exacerbations was required by 9.5% of patients, including 9.2% requiring >= 1 emergency department visit and 1.1% requiring >= 1 hospital admission. Conclusions: In this global sample representing community practice, a significant proportion of patients with physician-assessed mild asthma had considerable clinical burden and HCRU.

Published
2022
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12. Relative efficacy and safety of inhaled corticosteroids in patients with asthma: Systematic review and network meta-analysis

Author

Bradley, Chipps, Ben, Taylor, Valentina, Bayer, Asif, Shaikh, Giselle, Mosnaim, Jennifer, Trevor, Sheri, Rogers, Michael, Del Aguila, Dara, Paek, and Michael E, Wechsler

Subjects
Treatment Outcome, Drug-Related Side Effects and Adverse Reactions, Adrenal Cortex Hormones, Administration, Inhalation, Humans, Drug Therapy, Combination, Anti-Asthmatic Agents, Asthma
Abstract

Inhaled corticosteroids (ICSs) are recommended as first-line controller medications for persistent asthma. However, guidelines on the initial ICS doses, step-up and step-down algorithms, and when to switch to combination therapy vary.To understand the ideal starting doses of ICS therapy based on current evidence and to systematically compare low, moderate, and high starting doses of ICSs as monotherapy and in combination with long-acting β-agonists with respect to efficacy and safety.MEDLINE, Embase, and Cochrane databases were searched for relevant English-language articles published from 1980 to November 17, 2018. Randomized controlled trials with adult, steroid-naive, ICS-free (for ≥4 weeks) patients with asthma and a duration of 4 weeks or longer with an ICS treatment arm (monotherapy or combination therapy) were included. Separate fixed-effects Bayesian network meta-analyses were conducted on the extracted data for peak expiratory flow, forced expiratory volume in 1 second, nighttime rescue medication use, nighttime symptom score, and study withdrawal because of an adverse event.A total of 31 randomized controlled trials were analyzed. All starting doses of ICSs were comparable with respect to nighttime rescue medication use, nighttime symptom score, change in forced expiratory volume in 1 second, and study withdrawal because of an adverse event. Significant improvement in morning peak expiratory flow was observed with high-dose ICSs and with low- and moderate-dose ICSs and long-acting β-agonists than with low-dose ICSs.Overall, a high starting dose of ICSs had no additional clinical benefit in 3 of the 4 efficacy parameters compared with low or moderate ICS doses for controlling moderate to severe asthma but might have potential safety concerns.

Published
2020

15. Asthma control and disease burden in patients with asthma and allergic comorbidities

Author

Brandee Paknis, Engels N. Obi, Abhishek Kavati, Bradley Chipps, and Lulu K Lee

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Comorbidity, 03 medical and health sciences, 0302 clinical medicine, Cost of Illness, Quality of life, Adrenal Cortex Hormones, immune system diseases, Internal medicine, Asthma control, Adrenergic beta-Agonists, Hypersensitivity, medicine, Humans, Immunology and Allergy, In patient, 030212 general & internal medicine, Intensive care medicine, Disease burden, Aged, Retrospective Studies, Asthma, business.industry, Retrospective cohort study, Middle Aged, medicine.disease, respiratory tract diseases, 030228 respiratory system, Pediatrics, Perinatology and Child Health, Quality of Life, Female, business
Abstract

To assess asthma control and associations with health-related quality of life (HRQoL) and economic outcomes among patients with asthma and allergic comorbidities treated with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) combination therapy.Data from the 2011-2013 US National Health and Wellness Survey were used to identify patients with asthma currently treated with ICS and LABA combination therapy (N = 1923). Patients were included if they self-reported a physician diagnosis of asthma and at least one allergic/asthma-related comorbid condition (e.g., nasal allergies, atopic dermatitis). Asthma Control Test scores categorized patients as very poorly (scores ≤ 15; 29.3%), not well (16-19; 25.1%), or well controlled (20-25; 45.7%). Outcomes included HRQoL (SF-36v2; SF-12v2), work productivity and activity impairment, healthcare utilization (HRU), and annual indirect and direct costs. Generalized linear models, controlling for covariates, examined whether outcomes differed by asthma control.Over half of the patients had very poorly or not well-controlled asthma (54.4%). Patients with very poorly controlled versus well-controlled asthma reported significantly greater decreases in HRQoL, greater overall work impairment, and higher HRU (all, p0.05). Very poorly controlled patients incurred over double the indirect costs and nearly one and a half times the direct and total costs of well-controlled patients.Increasing level of asthma control was related to improved HRQoL and lower costs. The considerably high prevalence of uncontrolled asthma among patients on ICS and LABA suggests poor treatment adherence or unmet needs in current treatment and may require step-up therapy in appropriate patients according to clinical guidelines.

Published
2017
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16. Forced Expiratory Volume in 1 Second Variability Helps Identify Patients with Cystic Fibrosis at Risk of Greater Loss of Lung Function

Author

Wayne J. Morgan, Donald R. VanDevanter, David J. Pasta, Aimee J. Foreman, Jeffrey S. Wagener, Michael W. Konstan, Wayne Morgan, Michael Konstan, Ted Liou, Susanna McColley, Ann McMullen, Alexandra Quittner, Warren Regelmann, Clement Ren, Margaret Rosenfeld, Greg Sawicki, Michael Schechter, Donald VanDevanter, Jeffrey Wagener, Marlyn Woo, Dana Brasfield, Raymond Lyrene, Lawrence Sindel, Dion Roberts, John Carroll, Robert Warren, Louay Nassri, Paula Anderson, Mark Brown, Amy Silverthorn, Peggy Radford, Gerald Gong, Gregory Legris, Gerald Greene, Reddivalam Sudhakar, Arnold Platzker, Bruce Nickerson, Karen Hardy, Ivan Harwood, Gregory Shay, Bryon Quick, Allan Lieberthal, Richard Moss, Chris Landon, Yvonne Fanous, Jay Lieberman, Eugene Spiritus, Bradley Chipps, Ruth McDonald, Mark Pian, Gerd Cropp, Nancy Lewis, Dennis Nielson, Bertrand Shapiro, Jeff Wagener, Frank Accurso, Milene Saavedra, Karen Daigle, Jacob Hen, Regina Palazzo, Kathryn Dodds, Raj Pad-man, John Goodill, Glenna Winnie, Lea Davies, Tony Kriseman, Jorge Sallent, Joseph Chiaro, Martin Kubiet, Sue Goldfinger, Morton Schwartzman, Carlosenrique Diaz, Kevin Maupin, Eduardo Riff, David Geller, Floyd Livingston, Kunjana Mavunda, Jose Birriel, Luis Faverio, David Rosenberg, David Schaeffer, James Sherman, Mary Wagner, Michael Light, Bruce Schnapf, Gary Montgomery, Kevin Kirchner, Mark Weatherly, Daniel Caplan, Margaret Guill, Valera Hudson, Javeed Akhter, Donald Davison, Steven Boas, Youngran Chung, Rennee Latner, Gabriel Aljadeff, Youngran Chan, Jerome Kraut, Arvey Stone, John Lloyd Still, Girish Sharma, Lanie Eagleton, Patricia Hopkins, Umesh Chatrath, Lucille Lester, Young-Jee Kim, Veena Anthony, Howard Eigan, Michelle Howenstine, Pushpom James, Edward Gergesha, James Harris, Robert Plant, Veljko Zivkovich, Angela Collins, Edward Nassif, Richard Ahrens, Daniel Doornbos, Joseph Kanarek, Richard Leff, Pamela Shaw, Elanor Demoss, Maria Riva, Leonard Sullivan, Michael Anstead, Jamshed Kanga, Nemr Eid, Ron Morton, Bettina Hilman, Kim Jones, Scott Davis, Ralph Harder, Tom Lever, Anne Marie Cairns, Edgar Caldwell, Jonathan Zuckerman, Peter Mogayzel, Beryl Rosenstein, John McQuestion, Donna Perry, Samuel Rosenberg, Robert Gerstle, Andrew Colin, Mary Ellen Wohl, Allan Lapey, William Yee, Brian O'Sullivan, Robert Zwerdling, Ibrahim Abdulhamid, Adrian O'Hagan, John Schuen, Lawrence Kurlandsky, Richard Honicky, Douglas Homnick, John Marks, Bohdan Pichurko, Norma Maxvold, Samya Nasr, Richard Simon, Wan Tsai, Dana Kissner, John McNamara, Nancy Henry, Stephen Marker, Michael Pryor, Lynn Walker, Jim Woodward, Louis Mizell, Suzanne Miller, Daniel Rosenbluth, Philip Black, Michael McCubbin, Alan Cohen, Thomas Ferkol, George Mallory, Anthony Rejent, Bruce Rubin, Gavin Graff, Peter Konig, John Colombo, Peter Murphy, William Boyle, Worth Parker, Chandler Patton, Robert Zanni, Arthur Atlas, Nelson Turcios, Lourdes Laraya-Cuasay, Dorothy Bisberg, Helen Aguila, Sarah Allen, David James, Elizabeth Perkett, Marsha Thompson, Sonia Budhecha, Ruben Diaz, Jonathan Rosen, Robert Kaslovsky, Ronald Percciacante, Drucy Borowitz, Joseph Cronin, Colin McMahon, Lynne Quittell, Robert Giusti, Rubin Cohen, Joan DeCelie-Germana, Jack Gorvoy, Kalpan Patel, Meyer Kattan, Allen Dozor, Emily DiMango, Maria Berdella, Ran Anbar, Debra Ianuzzi, James Sexton, Catherine Tayag-Kier, John McBride, Karen Voter, Mary Dimaio, John Georgitis, Joseph Marc Majure, Maria Martinez, Clarke McIntosh, Margaret Leigh, Hugh Black, James Hughes, Anand Kantak, Robert Wilmott, Gregory Omlor, Robert Stone, Karen McCoy, James Acton, Carl Doershuk, Robert Fink, Michael Steffan, Pierre Vauthy, Patricia Joseph, Santiago Reyes, John Kramer, James Royall, Jay Eisenberg, Michael Wall, Stanley Fiel, Thomas Scanlin, Shroti Phadke, Joel Weinberg, William Sexauer, Stephen Wolf, Douglas Holsclaw, Debra Klein, Stuart Warren, Robert Kinsey, Carlos Perez, Muttiah Ganeshanathan, James Shinnick, Howard Panitch, Laurie Varlotta, Cynthia Robinson, Jose Rodriguez Santana, Mary Ann Passero, Jane Gwinn, Robert Baker, Michael Bowman, Patrick Flume, Daniel Brown, Roxanne Marville, James Wallace, Rodney Parry, Don Ellenburg, John Rogers, Ricky Mohon, Joel Ledbetter, Aram Hanissian, Robert Schoumacher, Preston Campbell, Christopher Harris, Bonnie Slovis, Dennis Stokes, Kathryn Hale, Marcia Katz, Dan Seilheimer, Marianne Sockrider, Allan Frank, James Daniel, James Cunningham, Iley Browning, John Bray, Amanda Dove, Fernando Mandujano, Larry Tremper, Martha Morse, Donna Willey-Courand, Steven Copenhaver, John Pohl, Bennie McWilliams, Marie Martine-Logvinoff, Marsh Wallace, Robert Klein, Rodolfo Amaro, Leslie Couch, Michael Brown, Claude Prestidge, Stephen Inscore, Andrew Lipton, Barbara Chatfield, Theodore Liou, Bruce Marshall, Thomas Lahiri, Donald Swartz, Laurie Whittaker, Karl Karlson, Ignacio Ropoll, Thomas Rubio, Joel Schmidt, David Thomas, John Osborn, Deborah Froh, Benjamin Gaston, Greg Elliott, Ronald Gibson, Bonnie Ramsey, Michael McCarthy, Lawrence Larson, David Ricker, Mark Robbins, Moira Aitken, Julia Emerson, Stephen Aronoff, Kathryn Moffett, Julie Biller, Mark Splaingard, Bradley Sullivan, Paul Pritchard, Stu Adair, Peter Holzwarth, Guillermo Dopico, Keith Meyer, Christopher Green, and Michael Rock

Subjects
Male, medicine.medical_specialty, Epidemiologic study, Time Factors, Cystic Fibrosis, Cystic fibrosis, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Predictive Value of Tests, Internal medicine, Forced Expiratory Volume, medicine, Humans, In patient, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Child, Lung, Lung function, business.industry, respiratory system, medicine.disease, respiratory tract diseases, 030228 respiratory system, Multicenter study, Predictive value of tests, Pediatrics, Perinatology and Child Health, Cardiology, Physical therapy, Female, business, Risk assessment, circulatory and respiratory physiology
Abstract

Objective To evaluate several alternative measures of forced expiratory volume in 1 second percent predicted (FEV 1 %pred) variability as potential predictors of future FEV 1 %pred decline in patients with cystic fibrosis. Study design We included 13 827 patients age ≥6 years from the Epidemiologic Study of Cystic Fibrosis 1994-2002 with ≥4 FEV 1 %pred measurements spanning ≥366 days in both a 2-year baseline period and a 2-year follow-up period. We predicted change from best baseline FEV 1 %pred to best follow-up FEV 1 %pred and change from baseline to best in the second follow-up year by using multivariable regression stratified by 4 lung-disease stages. We assessed 5 measures of variability (some as deviations from the best and some as deviations from the trend line) both alone and after controlling for demographic and clinical factors and for the slope and level of FEV 1 %pred. Results All 5 measures of FEV 1 %pred variability were predictive, but the strongest predictor was median deviation from the best FEV 1 %pred in the baseline period. The contribution to explanatory power (R 2 ) was substantial and exceeded the total contribution of all other factors excluding the FEV 1 %pred rate of decline. Adding the other variability measures provided minimal additional value. Conclusions Median deviation from the best FEV 1 %pred is a simple metric that markedly improves prediction of FEV 1 %pred decline even after the inclusion of demographic and clinical characteristics and the FEV 1 %pred rate of decline. The routine calculation of this variability measure could allow clinicians to better identify patients at risk and therefore in need of increased intervention.

Published
2014

18. Novel CFTR Variants Identified during the First 3 Years of Cystic Fibrosis Newborn Screening in California

Author

Terry Chin, Gregory F. Shay, Mark Pian, Muhammad M. Saeed, Mary Seastrand, Susan O'Bra, Kimberly N. Otsuka, Sanjay Jhawar, Maria Carmen Reyes, Martin Kharrazi, Bradley Chipps, Harry Opsimos, Christopher Landon, Danieli Salinas, Ruth Koepke, Jacquelyn Zirbes, Susan Lehto, Ann Thompson, Bruce Nickerson, Karen Hardy, Carlos Milla, Reddivalam Sudhakar, Eliezer Nussbaum, Lisa Prach, Dennis W. Nielson, Henry A. Wojtczak, and Steven Keiles

Subjects
Cystic Fibrosis, Cystic Fibrosis Transmembrane Conductance Regulator, medicine.disease_cause, Cystic fibrosis, DNA sequencing, Article, California, Pathology and Forensic Medicine, Neonatal Screening, Genotype, Medicine, Humans, Genetic Testing, Allele, Alleles, Genetic testing, Genetics, Newborn screening, Mutation, biology, medicine.diagnostic_test, business.industry, Infant, Newborn, Infant, medicine.disease, Cystic fibrosis transmembrane conductance regulator, biology.protein, Molecular Medicine, business, Algorithms
Abstract

California uses a unique method to screen newborns for cystic fibrosis (CF) that includes gene scanning and DNA sequencing after only one California-40 cystic fibrosis transmembrane conductance regulator (CFTR) panel mutation has been identified in hypertrypsinogenemic specimens. Newborns found by sequencing to have one or more additional mutations or variants (including novel variants) in the CFTR gene are systematically followed, allowing for prospective assessment of the pathogenic potential of these variants. During the first 3 years of screening, 55 novel variants were identified. Six of these novel variants were discovered in five screen-negative participants and three were identified in multiple unrelated participants. Ten novel variants (c.2554-2555insT, p.F1107L, c.-152G>C, p.L323P, p.L32M, c.2883-2886dupGTCA, c.2349-2350insT, p.K114del, c.-602A>T, and c.2822delT) were associated with a CF phenotype (42% of participants were diagnosed at 4 to 25 months of age), whereas 26 were associated with CFTR-related metabolic syndrome to date. Associations with the remaining novel variants were confounded by the presence of other diseases or other mutations in cis or by inadequate follow-up. These findings have implications for how CF newborn screening and follow-up is conducted and will help guide which genotypes should, and which should not, be considered screen positive for CF in California and elsewhere. © 2013 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Published
2013
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19. Associations Between Asthma Control and Health-Related Quality of Life Among Patients With Allergic Asthma on Inhaled Corticosteroids and Long-Acting Beta Agonists Combination Therapy

Author

Bradley Chipps, Engels N. Obi, Abhishek Kavati, Lulu Lee, and Brandee Paknis

Subjects
Pulmonary and Respiratory Medicine, Health related quality of life, medicine.medical_specialty, Combination therapy, business.industry, Allergic asthma, Inhaled corticosteroids, Critical Care and Intensive Care Medicine, Long acting beta, Internal medicine, Anesthesia, Asthma control, Adrenergic beta-Agonists, medicine, Combined Modality Therapy, Cardiology and Cardiovascular Medicine, business
Published
2016
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21. Contributors

Author

Andrea J. Apter, Ravi Aysola, Leonard B. Bacharier, Ronald C. Balkissoon, Elisabeth H. Bel, Bruce G. Bender, Robyn L. Boedefeld, Larry Borish, Arnaud Bourdin, Jean Bousquet, Jessica H. Boyd, Jeremy D. Bufford, William W. Busse, Charles B. Cairns, William J. Calhoun, Thomas B. Casale, Mario Castro, Mario Cazzola, Pascal Chanez, Reuben Cherniack, Bradley Chipps, Don W. Cockcroft, Susan J. Corbridge, Thomas C. Corbridge, C.J. Corrigan, Ronina A. Covar, Danita Czyzewski, Aaron Deykin, Elizabeth A. Erwin, David Evans, James B. Fink, James E. Fish, Anthony J. Frew, Anne L. Fuhlbrigge, Maureen George, Lynn B. Gerald, Peter G. Gibson, Stefano Guerra, Nicola A. Hanania, Susan M. Harding, Iftikhar Hussain, Susan L. Janson, Nizar N. Jarjour, Sujani Kakumanu, Kimberly Kelsay, Sarah B. Knowles, Monica Kraft, Marzena Krawiec, Robert F. Lemanske, John J. Lima, Njira L. Lugogo, Joan M. Mangan, John G. Mastronarde, John G. McCartney, Elizabeth L. McQuaid, Anandhi T. Murugan, Jennifer Altamura Namazy, Jonathan P. Parsons, Rodolfo M. Pascual, Anand C. Patel, Stephen P. Peters, Thomas A.E. Platts-Mills, Roy A. Pleasants, Jane Robinson, Bruce K. Rubin, Michael Schatz, Valerie A. Schend, Phillip E. Silkoff, David Slade, Raymond G. Slavin, Marianna M. Sockrider, Christine A. Sorkness, Joseph D. Spahn, Jonathan E. Spahr, John W. Steinke, Lora Stewart, Jeffrey R. Stokes, Robert C. Strunk, Stanley J. Szefler, Laurel R. Talabere, Karen J. Tien, Ilonka H. van Veen, Christine Waldman Wagner, Frederick S. Wamboldt, John O. Warner, Michael E. Wechsler, Glenn J. Whelan, Larry W. Williams, Sandra R. Wilson, Patrick H. Win, and Anne L. Wright

Published
2008
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22. Improvement in quality of life with omalizumab in patients with severe allergic asthma

Author

Roland Buhl, Bradley Chipps, Karen Thomas, C. Reisner, Howard Fox, and Kai-Michael Beeh

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Adolescent, Omalizumab, Antibodies, Monoclonal, Humanized, Severity of Illness Index, Quality of life, Severity of illness, Hypersensitivity, Medicine, Humans, In patient, Anti-Asthmatic Agents, Child, Asthma, Aged, Randomized Controlled Trials as Topic, business.industry, Antibodies, Monoclonal, Allergic asthma, General Medicine, Middle Aged, medicine.disease, humanities, Antibodies, Anti-Idiotypic, Clinical trial, Meta-analysis, Quality of Life, Female, business, medicine.drug
Abstract

Patients with severe persistent asthma experience daily symptoms and frequent serious exacerbations that contribute to a significant impairment of health-related quality of life (QoL).A pooled analysis was completed of six controlled clinical trials that evaluated the effect of add-on omalizumab on asthma-related QoL in patients with severe persistent allergic (IgE-mediated) asthma. Asthma-related QoL was assessed at baseline and treatment endpoint using the well-validated Juniper Asthma Quality of Life Questionnaire (AQLQ). Change from baseline in AQLQ total score was compared between treatments using analysis of covariance methods. The percentage of patients who achieved a clinically meaningful (or = 0.5-point) improvement in AQLQ total score was compared using the Mantel-Haenszel Chi-square test.The pooled patient population comprised 2548 patients (omalizumab, n = 1342; control, n = 1206), of whom 96% had severe persistent asthma according to the GINA 2002 classification. Omalizumab produced significantly greater improvements in AQLQ total score vs the control group (mean increases of 1.01 and 0.61 points, respectively; p0.001). In addition, significantly more omalizumab-treated patients achieved a clinically meaningful improvement in AQLQ total score than patients in the control group (66.3% vs 52.4%; p0.001).Add-on therapy with omalizumab improves QoL to a significant and clinically meaningful level in patients with severe persistent allergic asthma.

Published
2006

23. Asthma Control and Study Withdrawal in Patients With Versus Without Fixed Airflow Obstruction (2 Criteria): Post Hoc Analysis of a Budesonide/Formoterol Pressurized Metered-Dose Inhaler Study in Patients With Moderate to Severe Asthma

Author

James Zangrilli, Tom Uryniak, Bradley Chipps, Donald P. Tashkin, and Frank Trudo

Subjects
Pulmonary and Respiratory Medicine, Budesonide, business.industry, Airway obstruction, Critical Care and Intensive Care Medicine, medicine.disease, Metered-dose inhaler, Budesonide/formoterol, Asthma control, Anesthesia, Post-hoc analysis, medicine, Formoterol, Cardiology and Cardiovascular Medicine, business, medicine.drug, Asthma
Published
2012
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24. Reply

Author

Andrew H. Liu, Robert Zeiger, Todd Mahr, Nancy Ostrom, and Bradley Chipps

Subjects
Immunology, Immunology and Allergy
Published
2008
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25. CLASSIFICATION OF ASTHMA SEVERITY AMONG STEROID-NAÏVE PEDIATRIC SUBJECTS PREVIOUSLY RECEIVING SHORT-ACTING BETA2-AGONISTS: DO THE GUIDELINES NEED REVISITING?

Author

Paul Dorinsky, Amanda Emmett, Christine Sorkness, Bradley Chipps, Laura Sutton, and Joseph Spahn

Subjects
Pulmonary and Respiratory Medicine, Pediatrics, medicine.medical_specialty, B2 receptor, business.industry, medicine.medical_treatment, medicine, Asthma severity, Cardiology and Cardiovascular Medicine, Critical Care and Intensive Care Medicine, business, Steroid
Published
2005
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26. Ligelizumab for Chronic Spontaneous Urticaria.

Author

Bradley, Chipps

Subjects
*THERAPEUTIC use of monoclonal antibodies, *CHRONIC diseases, *DOSE-response relationship in biochemistry, *DRUG efficacy, *URTICARIA
Abstract

A review of the article "Ligelizumab for Chronic Spontaneous Urticaria," by G. Sussman et al, which appeared in a 2019 issue of the "New England Journal of Medicine" is presented.

Published
2020
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