Asthma and lower airway diseasePreseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations
Section snippets
Study design
The PROSE study (clinicaltrials.gov #NCT01430403) was a 3-arm, randomized, double-blind, double placebo-controlled, multicenter clinical trial conducted among participants receiving ongoing guidelines-based asthma care (Expert Panel Report-3 [EPR3]).1 The study enrolled 2 cohorts at 8 urban clinical research sites before the fall seasons of 2012 and 2013. The primary study objectives were to compare (1) omalizumab with placebo and (2) omalizumab with a boost in ICS (with total daily dose not to
Participant enrollment characteristics
Before the fall seasons of 2012 and 2013, 345 and 382 participants, respectively, were enrolled in the 4- to 9-month run-in phase of our protocol. Of these 727 participants, 513 were subsequently randomized at the end of the run-in phase into the 3 treatment arms, and 478 were included in the mITT population (Fig 1). Characteristics of the mITT participants are provided in Table I and Table E3 in this article's Online Repository at www.jacionline.org. Median adherence to asthma medications
Discussion
In the PROSE study we showed, in the context of our first primary objective, that a 4-month targeted treatment strategy with the addition of omalizumab beginning 4 to 6 weeks before the start of a school year to ongoing guidelines-based management significantly reduced asthma exacerbations during the fall season among at-risk inner-city youth (Fig 2, A). This seasonal approach in treatment adjustment represents a first-time report of this novel strategy aiming to more effectively prevent
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This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contracts HHSN272200900052C and HHSN272201000052I. Additional support was provided by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, under grants NCRR/NIH UL1TR000451, 1UL1RR025780, UL1TR000075 and NCATS/NIH UL1 TR000154, UL1 TR000077-04, NCATS/NIH UL1TR000040, UL1TR000150, and UL1TR001105, NIH NIAID 5R01AI098077, and UM1AI109565. The following were donated: omalizumab and matching placebo by Novartis and fluticasone and matching placebo by GlaxoSmithKline under a clinical trial agreement with the University of Wisconsin–Madison; EpiPens by Mylan; and Ayr nasal rinse by B.F. Ascher & Company.
Disclosure of potential conflict of interest: S. J. Teach has received grants from Novartis, PCORI, the Fight for Children Foundation, the Stewart Foundation, EJF Philanthropies, the National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID), and the NIH/National Heart, Lung, and Blood Institute (NHLBI). M. Gill has received grants from the NIH/NIAID Inner City Asthma Consortium II and the NIH/NIAID R01. C. A. Sorkness has received grants from the NIH/NIAID, the NIH/NHLBI, and Novartis. S. J. Arbes has a contract with the NIH/NIAID. A. Calatroni, J. J. Wildfire, and K. A. Grindle have received grants from the NIH/NIAID. J. A. Pongracic received the study drug for this study from Genentech, has a subcontract for the NIAID-sponsored Inner City Asthma Consortium from the University of Wisconsin and has received the study drug for a food allergy clinical trial from Genentech. C. M. Kercsmar has received a grant from the NIH and has received personal fees from GlaxoSmithKline. G. K. Khurana Hershey and E. M. Zoratti have received grants from the NIH. R. S. Gruchalla has served as a special government employee for the Center for Biologics Evaluation and Research and has consulted for the Massachusetts Medical Society. A. H. Liu has served as a member of a data monitoring committee for GlaxoSmithKline and has received payment for lectures from Merck. M. Kattan has received a grant from the NIH/NIAID and is on the advisory board for Novartis Pharma. J. E. Gern has received grants from the NIH, GlaxoSmithKline, and Merck; has consultant arrangements with GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Genentech, Amgen, and Novartis; and has stock/stock options in 3V BioSciences. W. W. Busse has received grants from the NIH/NIAID; has received partial study funding, drug, and placebo from Novartis; is on Data Safety Monitoring Boards for Boston Scientific and Circassia; is on the Study Oversight Committee for ICON; and has consultant arrangements with Novartis, GlaxoSmithKline, Genentech, Roche, Pfizer, Merck, Boehringer Ingelheim, Sanofi, AstraZeneca, Gilead, Teva, Tekeda, and Aerocrine. S. J. Szefler has received grants from the NIAID-sponsored Inner City Asthma Consortium and GlaxoSmithKline; has consultant arrangements with Merck, Boehringer Ingelheim, Genentech, GlaxoSmithKline, Aerocrine, Novartis, and AstraZeneca; and has received payment for lectures from Merck. The rest of the authors declare that they have no relevant conflicts of interest.