Document Detail


Onset and duration of attenuation of exercise-induced bronchoconstriction in children by single-dose of montelukast.
MedLine Citation:
PMID:  22221440     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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 (FEV(1)) ≥70% predicted and maximum percentage fall in FEV(1) 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 FEV(1) after exercise challenge 2 hours postdose. Secondary end points included maximum percentage fall in FEV(1) after the 24-hour postdose challenge; each of the following at 2 and 24 hours postdose-maximum percentage fall in FEV(1) categorized as <10%, 10-20%, or >20%; area under the curve (AUC) during 60 minutes postchallenge; time to recovery of FEV(1) to within 5% of preexercise baseline; and need for rescue medication. The mean maximum percentage fall in FEV(1) 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 FEV(1) 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.
Authors:
Yasmine S Wasfi; James P Kemp; César Villarán; Rachid Massaad; Wenjing Xin; Steven S Smugar; Barbara A Knorr; George Philip
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Allergy and asthma proceedings : the official journal of regional and state allergy societies     Volume:  32     ISSN:  1539-6304     ISO Abbreviation:  Allergy Asthma Proc     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2012-01-06     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9603640     Medline TA:  Allergy Asthma Proc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  453-9     Citation Subset:  IM    
Affiliation:
Merck & Co., Inc, Whitehouse Station, New Jersey, USA.
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