Montelukast versus salmeterol in patients with asthma and exercise-induced bronchoconstriction. Montelukast/Salmeterol Exercise Study Group

J Allergy Clin Immunol. 1999 Sep;104(3 Pt 1):547-53. doi: 10.1016/s0091-6749(99)70322-2.


Background: Montelukast, a leukotriene receptor antagonist, and salmeterol, a long-acting beta(2)-receptor agonist, each have demonstrated benefits in the treatment of exercise-induced bronchoconstriction (EIB) in short-term studies. Direct comparisons between these agents in long-term studies are limited.

Objective: We sought to compare montelukast and salmeterol in the long-term treatment of EIB.

Methods: One hundred ninety-seven patients with mild asthma and a postexercise fall in FEV(1) of at least 18% were randomized (double-blind) to receive montelukast 10 mg once daily or salmeterol 50 microg twice daily for 8 weeks. Exercise challenge was repeated at day 3, week 4, and week 8 after randomization near the end of the dosing interval for both drugs. The primary efficacy endpoint was the maximal percent fall in postexercise FEV(1) at week 8.

Results: Montelukast was effective in treating EIB without inducing tolerance and provided superior (P </=.001) protection than salmeterol at weeks 4 and 8, with comparable protection at day 3. The frequency of respiratory clinical adverse events (P =.046) and discontinuations because of clinical adverse events (P =.052) were less with montelukast.

Conclusion: The effect of montelukast was greater than that of salmeterol in the chronic treatment of EIB over a period of 8 weeks in patients with mild asthma as demonstrated by effect size, maintenance of effect, and fewer respiratory clinical adverse events during the study period. Montelukast may be a better alternative to salmeterol as a controller agent for the chronic treatment of EIB.

Publication types

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

MeSH terms

  • Acetates / therapeutic use*
  • Adolescent
  • Adult
  • Albuterol / analogs & derivatives*
  • Albuterol / therapeutic use
  • Asthma, Exercise-Induced / drug therapy*
  • Bronchial Diseases / drug therapy
  • Bronchodilator Agents / therapeutic use*
  • Constriction, Pathologic
  • Cyclopropanes
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Quinolines / therapeutic use*
  • Salmeterol Xinafoate
  • Single-Blind Method
  • Sulfides


  • Acetates
  • Bronchodilator Agents
  • Cyclopropanes
  • Quinolines
  • Sulfides
  • Salmeterol Xinafoate
  • montelukast
  • Albuterol