Asthma and lower airway diseaseFactors associated with asthma exacerbations during a long-term clinical trial of controller medications in children
Section snippets
Methods
Details of the PACT study and its procedures have been reported4 and are briefly summarized. PACT was a multicenter 48-week randomized, double-blind, placebo-controlled, double-dummy, parallel-group study of 285 children 6 to 14 years of age with documented mild-moderate persistent asthma, screening FEV1 ≥80% predicted, and methacholine reactivity. Treatments compared were fluticasone propionate 100 μg twice daily (FP monotherapy), FP 100 μg/salmeterol 50 μg in the morning and salmeterol 50 μg
Results
A total of 231 asthma exacerbations occurred in 48% of the participants during the course of the treatment phase. Twenty-two percent (n = 64) had 2 or more exacerbations (Fig 1). Of the exacerbations, 74 (53%), 35 (26%), and 29 (21%) were first, second, and third exacerbations, respectively. The mean ± SD (median) time to the first exacerbation was 127 ± 103 (99) days.
Discussion
Our analysis of asthma exacerbations of children with mild-to-moderate asthma enrolled in the 1-year multicenter PACT study using an extensive panel of physiologic and biologic markers revealed important features associated with the occurrence of an exacerbation.
Host and environmental factors that increase the risk of asthma exacerbations in children and those that could be targeted by interventions are not well defined. Of the numerous baseline historical, phenotypic, and immunologic and
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Supported by grants 5U10HL064287, 5U10HL064288, 5U10HL064295, 5U10HL064307, 5U10HL064305, and 5U10HL064313 from the National Heart, Lung, and Blood Institute; General Clinical Research Centers at Washington University School of Medicine (M01 RR00036); and National Jewish Medical and Research Center (M01 RR00051).
Disclosure of potential conflict of interest: R. A. Covar has received honoraria from Aerocrine NIOX and has received research support as a coinvestigator from Abbott Laboratories. S. J. Szefler has served as a consultant for AstraZeneca, GlaxoSmithKline, Aventis, Genentech, and Merck and has received research grants from the National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) Childhood Asthma Management Program, NHLBI Childhood Asthma Research and Education, the NIH/NHLBI Asthma Clin Res Network, the NIH/National Institute of Allergy and Infectious Diseases Inner-City Asthma Consortium, and Ross Pharmaceuticals. R. S. Zeiger has served as a consultant for Aerocrine, AstraZeneca, Dynavax, Genentech, Merck, Novartis, and GlaxoSmithKline and has received research support from Sanofi-Aventis, Teva-Pharmaceuticals, Merck, AstraZeneca, GlaxoSmithKline, and Genentech. C. A. Sorkness has served on the speakers' bureau for GlaxoSmithKline and has received research support from GlaxoSmithKline and Pharmaxis. The rest of the authors have declared that they have no conflict of interest.