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Onset and duration of attenuation of exercise-induced bronchoconstriction in children by single-dose of montelukast

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Abstract:

Single-dose montelukast attenuates exercise-induced bronchoconstriction (EIB) in adults within 2 hours postdose and lasting through 24 hours. This study evaluated the onset and duration of EIB attenuation in children after a single dose of montelukast. A randomized, double-blind, placebo-controlled, two-period crossover study was performed. Patients (n = 66) aged 4‐14 years, with preexercise forced expiratory volume in 1 second of (FEV1) ≥70% predicted and maximum percentage fall in FEV1 of ≥20% at two screening exercise challenges were eligible. Patients were to receive single-dose montelukast (4 or 5 mg) or placebo before performing standardized exercise challenges at 2 and 24 hours postdose. A 3- to-7-day washout separated the two crossover periods. The primary end point was maximum percentage fall in FEV1 after exercise challenge 2 hours postdose. Secondary end points included maximum percentage fall in FEV1 after the 24-hour postdose challenge; each of the following at 2 and 24 hours postdose—maximum percentage fall in FEV1 categorized as <10%, 10‐20%, or >20%; area under the curve (AUC) during 60 minutes postchallenge; time to recovery of FEV1 to within 5% of preexercise baseline; and need for rescue medication. The mean maximum percentage fall in FEV1 after the 2-hour postdose exercise challenge was significantly attenuated after single-dose montelukast compared with placebo (15.35% versus 20.00%; p = 0.020). Montelukast was also significantly more effective than placebo for maximum percentage fall after the 24-hour challenge (12.92% versus 17.25%; p = 0.005), the categorized maximum percent fall in FEV1 at 2 hours (p = 0.034), and AUC at 2 hours (p = 0.022) and 24 hours (p = 0.013). Single-dose montelukast provided rapid and sustained EIB attenuation in children. Clinicaltrials.gov identifier: NCT00534976

Keywords: Asthma; FEV1; children; crossover study; exercise-induced bronchoconstriction; montelukast; pediatric; placebo; prevention; randomized trial

Document Type: Research Article

DOI: https://doi.org/10.2500/aap.2011.32.3482

Publication date: 2011-11-01

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  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

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    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

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    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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