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3. The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions

Author

Georas, Steve N, Wright, Rosalind J, Ivanova, Anastasia, Israel, Elliot, LaVange, Lisa M, Akuthota, Praveen, Carr, Tara F, Denlinger, Loren C, Fajt, Merritt L, Kumar, Rajesh, O’Neal, Wanda K, Phipatanakul, Wanda, Szefler, Stanley J, Aronica, Mark A, Bacharier, Leonard B, Burbank, Allison J, Castro, Mario, Alexander, Laura Crotty, Bamdad, Julie, Cardet, Juan Carlos, Comhair, Suzy AA, Covar, Ronina A, DiMango, Emily A, Erwin, Kim, Erzurum, Serpil C, Fahy, John V, Gaffin, Jonathan M, Gaston, Benjamin, Gerald, Lynn B, Hoffman, Eric A, Holguin, Fernando, Jackson, Daniel J, James, John, Jarjour, Nizar N, Kenyon, Nicholas J, Khatri, Sumita, Kirwan, John P, Kraft, Monica, Krishnan, Jerry A, Liu, Andrew H, Liu, Mark C, Marquis, M Alison, Martinez, Fernando, Mey, Jacob, Moore, Wendy C, Moy, James N, Ortega, Victor E, Peden, David B, Pennington, Emily, Peters, Michael C, Ross, Kristie, Sanchez, Maria, Smith, Lewis J, Sorkness, Ronald L, Wechsler, Michael E, Wenzel, Sally E, White, Steven R, Zein, Joe, Zeki, Amir A, Noel, Patricia, Billheimer, Dean, Bleecker, Eugene R, Branch, Emily, Conway, Michelle, Daines, Cori, Deaton, Isaac, Evans, Alexandria, Field, Paige, Francisco, Dave, Hastie, Annette T, Hmieleski, Bob, Krings, Jeffrey O, Liu, Yanqin, Merchen, Janell L, Meyers, Deborah A, Narendran, Nirushan, Peters, Stephen P, Pippins, Anna, Rank, Matthew A, Schunk, Ronald, Skeps, Raymond, Wright, Benjamin, Banzon, Tina M, Bartnikas, Lisa M, Baxi, Sachin N, Betapudi, Vishwanath, Brick, Isabelle, Brockway, Conor, Casale, Thomas B, Castillo-Ruano, Kathleen, Cinelli, Maria Angeles, Crestani, Elena, Cunningham, Amparito, Day-Lewis, Megan, Diaz-Cabrera, Natalie, DiMango, Angela, Esty, Brittany, Fandozzi, Eva, Fernandez, Jesse, and Fitzpatrick, Elizabeth

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Lung, Asthma, Precision Medicine, Clinical Trials and Supportive Activities, Clinical Research, Respiratory, Good Health and Well Being, Advisory Committees, Biomarkers, Clinical Protocols, Clinical Trials, Phase II as Topic, Humans, Research Design, Severity of Illness Index, Tomography, X-Ray Computed, Severe asthma, precision medicine, adaptive clinical trial design, asthma exacerbation, type 2 asthma, non-type 2 asthma, patient advisory committee, biomarker, PrecISE Study Team, non–type 2 asthma, Immunology, Allergy
Abstract

Asthma is a heterogeneous disease, with multiple underlying inflammatory pathways and structural airway abnormalities that impact disease persistence and severity. Recent progress has been made in developing targeted asthma therapeutics, especially for subjects with eosinophilic asthma. However, there is an unmet need for new approaches to treat patients with severe and exacerbation-prone asthma, who contribute disproportionately to disease burden. Extensive deep phenotyping has revealed the heterogeneous nature of severe asthma and identified distinct disease subtypes. A current challenge in the field is to translate new and emerging knowledge about different pathobiologic mechanisms in asthma into patient-specific therapies, with the ultimate goal of modifying the natural history of disease. Here, we describe the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network, a groundbreaking collaborative effort of asthma researchers and biostatisticians from around the United States. The PrecISE Network was designed to conduct phase II/proof-of-concept clinical trials of precision interventions in the population with severe asthma, and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Using an innovative adaptive platform trial design, the PrecISE Network will evaluate up to 6 interventions simultaneously in biomarker-defined subgroups of subjects. We review the development and organizational structure of the PrecISE Network, and choice of interventions being studied. We hope that the PrecISE Network will enhance our understanding of asthma subtypes and accelerate the development of therapeutics for severe asthma.

Published
2022

7. Effects of combination treatment with tezepelumab and allergen immunotherapy on nasal responses to allergen: A randomized controlled trial

Author

Corren, Jonathan, Larson, David, Altman, Matthew C., Segnitz, R. Max, Avila, Pedro C., Greenberger, Paul A., Baroody, Fuad, Moss, Mark H., Nelson, Harold, Burbank, Allison J., Hernandez, Michelle L., Peden, David, Saini, Sarbjit, Tilles, Stephen, Hussain, Iftikhar, Whitehouse, Don, Qin, Tielin, Villarreal, Miguel, Sever, Michelle, Wheatley, Lisa M., Nepom, Gerald T., and Sanda, Srinath

Published
2023
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8. The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions

Author

Billheimer, Dean, Bleecker, Eugene R., Branch, Emily, Conway, Michelle, Daines, Cori, Deaton, Isaac, Evans, Alexandria, Field, Paige, Francisco, Dave, Hastie, Annette T., Hmieleski, Bob, Krings, Jeffrey O., Liu, Yanqin, Merchen, Janell L., Meyers, Deborah A., Narendran, Nirushan, Peters, Stephen P., Pippins, Anna, Rank, Matthew A., Schunk, Ronald, Skeps, Raymond, Wright, Benjamin, Banzon, Tina M., Bartnikas, Lisa M., Baxi, Sachin N., Betapudi, Vishwanath, Brick, Isabelle, Brockway, Conor, Casale, Thomas B., Castillo-Ruano, Kathleen, Cinelli, Maria Angeles, Crestani, Elena, Cunningham, Amparito, Day-Lewis, Megan, Diaz-Cabrera, Natalie, DiMango, Angela, Esty, Brittany, Fandozzi, Eva, Fernandez, Jesse, Fitzpatrick, Elizabeth, Forth, Victoria E., Gentile, Katarina, Gubernick, David, Gueye-Ndiaye, Seyni, Gunnlaagsson, Sigfus, Hauptmann, Marissa, Hudey, Stephanie N., Imanirad, Donya S., Kaage, Tiffani, Kolinsky, Nicholas, LaBere, Brenna, Lai, Peggy Sue, Le, Meghan, Ledford, Dennis K., Lockey, Richard, Louisias, Margee, Macginnitie, Andrew J., Maciag, Michelle C., O’Neill, Allison, Pepper, Amber N., Permaul, Perdita, Pugh, Mya, Queheillalt, Dianna, Saroya, Tarnjot, Sheehan, William, Smith, Catherine, Socolovsky, Carmela, Treffeisen, Else, Trippa, Lorenzo, Tulchinsky, Abigail, Yee, Christina, Carter, Tina, Fu, Jun, Garcia, Vanessa, Hixon, Jenny, Jackson, Carly, Ji, Yuan, Kalhan, Ravi, Kaur, Opinderjit, Li, Grace, Makhija, Melanie M., Maleckar, Spring, Naureckas, Edward T., Peters, Anju T., Press, Valerie, Qureshi, Mehreen, Reyfman, Paul A., Rosenberg, Sharon R., Ryba, Dominika, Sheng, Jianrong, Xu, Ben, Alam, Rafeul, Anderson, Darci, Belimezova, Sonya, Bitzan, Jennifer, Chupp, Geoffrey, Clark, Brian J., Cohn, Lauren, Cruse, Margaret Hope, Estrom, Jean, Freid, Leah, Villalobos, Jose Gomez, Grant, Nicole, Guntur, Vamsi P., Holm, Carole, Kolakowski, Christena, Manka, Laurie A., Miyazawa, Naomi, Pak, Juno, Pruitt, Diana M., Sharma, Sunita, Stevens, Allen D., Thomas, Kisori, Tippin, Brooke, Valente, Karissa, Wainscoat, Cynthia L., White, Michael P., Winnica, Daniel, Ye, Shuyu, Zeitlin, Pamela L., Bach, Julia, Brownell, Joshua, Castro, Lauren, DeLisa, Julie, Fain, Sean B., Fichtinger, Paul S., Floerke, Heather, Gern, James E., Goswamy, Vinay, Grogan, Jenelle, Hasse, Wendy, Kelley, Rick L., Klaus, Danika, LaBedz, Stephanie, Lowell, Paige, Maddox, Andrew, Mathur, Sameer K., McIntyre, Amanda, Norwick, Lourdes M., Nyenhuis, Sharmilee M., O’Brien, Matthew J., Palas, Tina, Pappalardo, Andrea A., Potter, Mark, Ramratnam, Sima K., Rosenberg, Daniel L., Schauberger, Eric M., Schiebler, Mark L., Schraml, Angela, Sorkness, Ronald L., Taki, Mohamed, Tattersall, Matthew C., Torres, Jissell, Wollet, Lori, Abi-Saleh, Simon, Bendy, Lisa, Borish, Larry, Chmiel, James F., Dix, Aska, France, Lisa, Gammell, Rebecca, Gluvna, Adam, Hirth, Brittany, Hu, Bo, Hyser, Elise, Kloepfer, Kirsten M., Koo, Michelle, Krupp, Nadia L., Labadia, Monica, Lawrence, Joy, Logan, Laurie, Marko, Angela, Matuska, Brittany, Murphy, Deborah, Owensby, Rachel, Roesch, Erica A., Sanders, Don B., Sharp, Jackie, Teague, W. Gerald, Veri, Laura, Shifflett, Kristin Wavell, Camiolo, Matt, Collins, Sarah, Demas, Jessa, Elvin, Courtney, Gauthier, Marc C., Ilnicki, Melissa, Ingram, Jenn, Lane, Lisa, Nouraie, Seyed Mehdi, Trudeau, John B., Zhang, Michael, Barry, Jeffrey, Brickner, Howard, Celso, Janelle, Cernelc-Kohan, Matejka, Diaz, Damaris, Du, Ashley, Jain, Sonia, Liu, Neiman, Nazir, Yusife, Ryu, Julie, Vijayanand, Pandurangan, Almario, Rogelio, Baum, Ariana, Brown, Kellen, Chan, Marilynn H., Gale, Barbara, Haczku, Angela, Harper, Richart W., Heromin, Raymond, Kivler, Celeste, Kuhn, Brooks T., Ly, Ngoc P., McCourt, Paula, Orain, Xavier, Plough, Audrey, Ramirez, Karla, Roberts, Ellese, Schivo, Michael, Singapuri, Amisha, Tham, Tina, Tompkins, Daniel, Twitmyer, Patricia Michelle, Vi, Jade, Atha, Jarron, Bedard, Jennifer, Boomer, Jonathan S., Chung, Andrew, Curtis, Vanessa, Hall, Chase S., Hart, Emily, Jackson, Fatima, Kemp, Pamela, Maxwell, Sharli, Messplay, Maggie, Ramirez, Crystal, Thompson, Brynne, Britt, Ashley, Bryan, Hope, Gotman, Nathan M., Jiang, Yue, Kosorok, Michael R., Mauger, David T., Meekins, Kelsey, Mollenhauer, Jeanette K., Moody, Sarah, Ritz, Cheyanne, Schwartz, Stefanie, Thomlinson, Chalmer, Wilson, Nicole, Georas, Steve N., Wright, Rosalind J., Ivanova, Anastasia, Israel, Elliot, LaVange, Lisa M., Akuthota, Praveen, Carr, Tara F., Denlinger, Loren C., Fajt, Merritt L., Kumar, Rajesh, O’Neal, Wanda K., Phipatanakul, Wanda, Szefler, Stanley J., Aronica, Mark A., Bacharier, Leonard B., Burbank, Allison J., Castro, Mario, Crotty Alexander, Laura, Bamdad, Julie, Cardet, Juan Carlos, Comhair, Suzy A.A., Covar, Ronina A., DiMango, Emily A., Erwin, Kim, Erzurum, Serpil C., Fahy, John V., Gaffin, Jonathan M., Gaston, Benjamin, Gerald, Lynn B., Hoffman, Eric A., Holguin, Fernando, Jackson, Daniel J., James, John, Jarjour, Nizar N., Kenyon, Nicholas J., Khatri, Sumita, Kirwan, John P., Kraft, Monica, Krishnan, Jerry A., Liu, Andrew H., Liu, Mark C., Marquis, M. Alison, Martinez, Fernando, Mey, Jacob, Moore, Wendy C., Moy, James N., Ortega, Victor E., Peden, David B., Pennington, Emily, Peters, Michael C., Ross, Kristie, Sanchez, Maria, Smith, Lewis J., Wechsler, Michael E., Wenzel, Sally E., White, Steven R., Zein, Joe, Zeki, Amir A., and Noel, Patricia

Published
2022
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12. Inhaled endotoxin induces a systemic neutrophil response without affecting cardiovascular measures in a randomized cross-over exposure study

Author

Schworer, Stephen A., primary, Hinderliter, Alan L., additional, Caughey, Melissa C., additional, Robinette, Carole, additional, Chason, Kelly D., additional, Li, Haolin, additional, Zhou, Haibo, additional, Sood, Amika K., additional, Burbank, Allison J., additional, Peden, David B., additional, and Hernandez, Michelle L., additional

Published
2024
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19. Risk Factors for Respiratory Viral Infections: A Spotlight on Climate Change and Air Pollution

Author

Burbank,Allison J and Burbank,Allison J

Abstract

Allison J Burbank Division of Pediatric Allergy and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USACorrespondence: Allison J Burbank, 5008B Mary Ellen Jones Building, 116 Manning Dr, CB#7231, Chapel Hill, NC, 27599, USA, Tel +1 919 962 5136, Fax +1 919 962 4421, Email Allison_burbank@med.unc.eduAbstract: Climate change has both direct and indirect effects on human health, and some populations are more vulnerable to these effects than others. Viral respiratory infections are most common illnesses in humans, with estimated 17 billion incident infections globally in 2019. Anthropogenic drivers of climate change, chiefly the emission of greenhouse gases and toxic pollutants from burning of fossil fuels, and the consequential changes in temperature, precipitation, and frequency of extreme weather events have been linked with increased susceptibility to viral respiratory infections. Air pollutants like nitrogen dioxide, particulate matter, diesel exhaust particles, and ozone have been shown to impact susceptibility and immune responses to viral infections through various mechanisms, including exaggerated or impaired innate and adaptive immune responses, disruption of the airway epithelial barrier, altered cell surface receptor expression, and impaired cytotoxic function. An estimated 90% of the world’s population is exposed to air pollution, making this a topic with high relevance to human health. This review summarizes the available epidemiologic and experimental evidence for an association between climate change, air pollution, and viral respiratory infection.Keywords: viral respiratory infection, climate change, air pollution, influenza, respiratory syncytial virus, rhinovirus, nitrogen dioxide, ozone, diesel exhaust particles, particulate matter

Published
2023

28. Development of a screening protocol to identify persons who are responsive to wood smoke particle-induced airway inflammation with pilot assessment of GSTM1 genotype and asthma status as response modifiers

Author

Alexis, Neil E., primary, Zhou, Laura Y., additional, Burbank, Allison J., additional, Almond, Martha, additional, Hernandez, Michelle L., additional, Mills, Katherine H., additional, Noah, Terry L., additional, Wells, Heather, additional, Zhou, Haibo, additional, and Peden, David B., additional

Published
2022
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33. Identification of Persons Who Are Responsive To Wood Smoke Particle-Induced Airway Inflammation With Assessment of The Effect of GSTM1, Asthma Status And Sex On This Response.

Author

Peden, David B., primary, Zhou, Laura, additional, Burbank, Allison J., additional, Almond, Martha, additional, Hernandez, Michelle L., additional, Mills, Katherine H, additional, Noah, Terry L., additional, Wells, Heather, additional, Zhou, Haibo, additional, and Alexis, Neil E., additional

Published
2021
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40. Validation of an app-based portable spirometer in adolescents with asthma.

Author

Ring, Brian, Burbank, Allison J., Mills, Katherine, Ivins, Sally, Dieffenderfer, James, and Hernandez, Michelle L.

Subjects
*ASTHMA, *TEENAGERS, *SPIROMETRY equipment, *MOBILE apps, *FORCED expiratory volume, *VITAL capacity (Respiration)
Abstract

Objective measurements of asthma impairment could aid teens in recognition of changes in asthma status over time. Ready access to a conventional spirometer is not realistic outside of the clinical setting. In this proof-of-concept study, we compared the performance of the VitalFlo mobile spirometer to the nSpire KoKo® sx1000 spirometer for accuracy in measuring Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) in adolescents with asthma. Two hundred forty pulmonary function measurements were collected from 48 adolescents with persistent asthma from the University of North Carolina's pediatric allergy and pulmonology subspecialty clinics. Participants performed spirometry with the nSpireKoKo® sx1000 spirometer and the VitalFlo spirometer during their clinic visits. 119 simulated FVC maneuvers were conducted on both devices to standardize measurements. Pearson correlations, Bland-Altman procedure, and two-sample comparison tests were performed to assess the relationship between the two spirometers. VitalFlo measurements were significantly highly correlated with nSpireKoKo® spirometer values for FEV1, (r2=0.721, [95% CI, 0.749 ± 0.120], P < 0.001) and moderately for FVC (r2= 0.617, [95% CI, 0.640 ± 0.130], P < 0.001) measurements. There were no statistically significant differences of the mean FEV1 (M = 0.00764, SD = 0.364, t(59)=0.16, P = 0.87) and FVC measurements (M = 0.00261, SD = 0.565, t(59)=0.036, P = 0.97.) between the VitalFlo and nSpireKoKo® systems. Both devices demonstrated significantly high correlation when comparing the automated FVC (r2 = 0.997, [95% CI, 1.00 ± 0.00974], P < 0.001) measurements. Bland-Altman plots did not demonstrate significant bias between devices for both FEV1 (0.00764 L) and FVC (0.00261 L) measurements. Lung function measurements from the VitalFlo mobile spirometer were comparable to a commercially-available spirometer commonly used in clinical settings. This validated app-based spirometer for home use has the potential to improve asthma self-management. [ABSTRACT FROM AUTHOR]

Published
2021
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47. Impact of asthma control on susceptibility to ambient air pollution among African American teens with asthma

Author

Hernandez, Michelle L., primary, Dhingra, Radhika, additional, Burbank, Allison J., additional, Todoric, Krista, additional, Loughlin, Ceila, additional, Frye, Marcia, additional, Duncan, Kelly E., additional, Robinette, Carole, additional, Mills, Katherine H., additional, Devlin, Robert, additional, Peden, David B., additional, and Sanchez, David Diaz, additional

Published
2018
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49. A proof-of-concept clinical study examining the NRF2 activator sulforaphane against neutrophilic airway inflammation

Author

Burbank, Allison J., Hernandez, Michelle, Aleman, Maria M., Pan, Yinghao, Duran, Charity G., Zhou, Haibo, Peden, David, Duckworth, Heather R., and Mills, Katherine H.

Abstract

Sulforaphane (SFN), a naturally occurring isothiocyanate found in cruciferous vegetables, is implicated as a possible therapy for airway inflammation via induction of the transcription factor NF-E2-related factor 2 (NRF2). In this proof-of-concept clinical study, we show that supplementation of SFN with broccoli sprout homogenate in healthy human subjects did not induce expression of antioxidant genes or protect against neutrophilic airway inflammation in an ozone-exposure model. Therefore, dietary sulforaphane supplementation is not a promising candidate for larger scale clinical trials targeting airway inflammation. Trial registration: NCT01625130 . Registered 19 June, 2012.

Published
2016
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