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This Article Full Text (PDF) Free All Versions of this Article: chest.07-0550v1 chest.07-0550v2 132/3/875    most recent Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My Personal Article Archive Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Philip, G. Articles by Reiss, T. F. Search for Related Content PubMed PubMed Citation Articles by Philip, G. Articles by Reiss, T. F.

Single-Dose Montelukast or Salmeterol as Protection Against Exercise-Induced Bronchoconstriction

From the Merck Research Laboratories, Rahway, NJ, USA (Drs. Philip, Legrand, Loeys, Langdon, and Reiss; the Colorado Allergy and Asthma Centers, PC, Denver, CO (Dr. Pearlman); and the Clinica Ricardo Palma, Lima, Peru (Dr. Villarán)

george_philip{at}merck.com

Abstract

Background and objectiveIt has been previously established that montelukast provides protection against exercise-induced bronchoconstriction (EIB) after a single dose. The present objective was to assess the onset and duration of this protective action in a trial that included both positive and negative controls.

MethodsA randomized, active- and placebo-controlled, double-blind, double-dummy, 3-way crossover study was conducted in 47 patients (ages 15--44 years) in whom exercise induced a 20-40% fall in forced expiratory volume in 1 s (FEV₁). In randomized sequence, patients received oral montelukast (10 mg), placebo, or inhaled salmeterol (50 µg) as a positive control. Dosing was followed by exercise challenges at 2, 8.5, and 24 h. The primary endpoint was maximum FEV₁ at 2 h postdose. Secondary endpoints included maximum FEV₁ at the 2 later timepoints, and other measures (including recovery time and need for ß-agonist rescue) at all timepoints.

ResultsMaximum FEV₁ magnitudes at 2, 8.5, and 24 h were significantly smaller after montelukast than after placebo (LS-means ± SE 13.2%±1.2%, 11.7%±1.2%, and 10.0%±1.1% versus 21.8%±1.2%, 16.8%±1.3%, and 14.0%±1.1%, respectively; p 0.001, < 0.01, and < 0.05). All secondary endpoint results supported the primary endpoint. Montelukast and salmeterol had similar efficacy at 2 and 8.5 h, but only montelukast was effective at 24 h.

ConclusionMontelukast provided significant protection against EIB having an onset within 2 h following a single oral dose and lasting for at least 24 h.[Trial Registration: http://clinicaltrials.gov/show/NCT00245570]

Key Words: leukotriene receptor antagonist • ß-adrenergic receptor agonist • long-acting ß-agonist • bronchospasm • bronchial asthma • exercise-induced bronchoconstriction