Single-dose montelukast or salmeterol as protection against exercise-induced bronchoconstriction

Chest. 2007 Sep;132(3):875-83. doi: 10.1378/chest.07-0550. Epub 2007 Jun 15.

Abstract

Background and objective: It 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.

Methods: A randomized, active-controlled and placebo-controlled, double-blind, double-dummy, three-way crossover study was conducted in 47 patients (age range, 15 to 44 years) in whom there was a 20 to 40% fall in FEV(1) following exercise (DeltaFEV(1)). In randomized sequence, patients received oral montelukast (10 mg), placebo, or inhaled salmeterol (50 microg) as a positive control. Dosing was followed by exercise challenges at 2, 8.5, and 24 h. The primary end point was maximum DeltaFEV(1) at 2 h postdose. Secondary end points included maximum DeltaFEV(1) at the two later time points, and other measures (including recovery time and need for beta-agonist rescue) at all time points.

Results: The maximum DeltaFEV(1) magnitudes at 2, 8.5, and 24 h were significantly smaller after montelukast administration than after placebo administration (least squares mean [+/- SE], 13.2 +/- 1.2%, 11.7 +/- 1.2%, and 10.0 +/- 1.1% vs 21.8 +/- 1.2%, 16.8 +/- 1.3%, and 14.0 +/- 1.1%, respectively; p <or= 0.001, < 0.01, and < 0.05). All secondary end point results supported the primary end point. Montelukast and salmeterol had similar efficacy at 2 and 8.5 h, but only montelukast was effective at 24 h.

Conclusion: Montelukast provided significant protection against EIB having an onset within 2 h following a single oral dose and lasting for at least 24 h.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / administration & dosage*
  • Acetates / pharmacokinetics
  • Adolescent
  • Adult
  • Albuterol / administration & dosage
  • Albuterol / analogs & derivatives
  • Albuterol / pharmacokinetics
  • Anti-Asthmatic Agents / administration & dosage*
  • Anti-Asthmatic Agents / pharmacokinetics
  • Bronchial Diseases / etiology*
  • Bronchial Diseases / metabolism
  • Bronchial Diseases / prevention & control*
  • Bronchodilator Agents / administration & dosage
  • Bronchodilator Agents / pharmacokinetics
  • Constriction, Pathologic / etiology
  • Constriction, Pathologic / metabolism
  • Constriction, Pathologic / prevention & control
  • Cross-Over Studies
  • Double-Blind Method
  • Drug Administration Schedule
  • Exercise*
  • Female
  • Forced Expiratory Volume
  • Humans
  • Male
  • Quinolines / administration & dosage*
  • Quinolines / pharmacokinetics
  • Salmeterol Xinafoate

Substances

  • Acetates
  • Anti-Asthmatic Agents
  • Bronchodilator Agents
  • Quinolines
  • Salmeterol Xinafoate
  • montelukast
  • Albuterol