Oral montelukast compared with inhaled salmeterol to prevent exercise-induced bronchoconstriction. A randomized, double-blind trial. Exercise Study Group

Ann Intern Med. 2000 Jan 18;132(2):97-104. doi: 10.7326/0003-4819-132-2-200001180-00002.

Abstract

Background: Montelukast, an oral, once-daily leukotriene receptor antagonist, provides protection against exercise-induced bronchoconstriction.

Objective: To evaluate the effect of 8 weeks of therapy with salmeterol aerosol or montelukast on exercise-induced bronchoconstriction in adults with asthma.

Design: 8-week multicenter, randomized, double-blind study.

Setting: 17 asthma treatment centers in the United States.

Patients: 191 adults with asthma who had documented exercise-induced bronchoconstriction.

Intervention: Qualified patients were randomly assigned to double-blind treatment with montelukast (10 mg once in the evening) or salmeterol (50 microg [2 puffs] twice daily).

Measurements: Changes in pre-exercise and postexercise challenge values; percentage inhibition in the maximal percentage decrease in FEV1; the area above the FEV1-time curve; and time to recovery of FEV1 at days 1 to 3, week 4, and week 8 of treatment.

Results: By day 3, similar and statistically significant reductions in maximal percentage decrease in FEV1 were seen with both therapies. Sustained improvement occurred in the montelukast group at weeks 4 and 8; at these time points, the bronchoprotective effect of salmeterol decreased significantly. At week 8, the percentage inhibition in the maximal percentage decrease in FEV1 was 57.2% in the montelukast group and 33.0% in the salmeterol group (P = 0.002). By week 8, 67% of patients receiving montelukast and 46% of patients receiving salmeterol had a maximal percentage decrease in FEV1 of less than 20%.

Conclusions: The bronchoprotective effect of montelukast was maintained throughout 8 weeks of study. In contrast, significant loss of bronchoprotection at weeks 4 and 8 was seen with salmeterol. Long-term administration of montelukast provided consistent inhibition of exercise-induced bronchoconstriction at the end of the 8-week dosing interval without tolerance.

Publication types

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

MeSH terms

  • Acetates / administration & dosage*
  • Acetates / adverse effects
  • Acetates / pharmacokinetics
  • Administration, Oral
  • Adolescent
  • Adult
  • Albuterol / administration & dosage
  • Albuterol / adverse effects
  • Albuterol / analogs & derivatives*
  • Albuterol / pharmacokinetics
  • Area Under Curve
  • Asthma, Exercise-Induced / physiopathology
  • Asthma, Exercise-Induced / prevention & control*
  • Bronchoconstriction / drug effects*
  • Bronchodilator Agents / administration & dosage*
  • Bronchodilator Agents / adverse effects
  • Bronchodilator Agents / pharmacokinetics
  • Cyclopropanes
  • Double-Blind Method
  • Female
  • Forced Expiratory Volume
  • Humans
  • Leukotriene Antagonists / administration & dosage*
  • Leukotriene Antagonists / adverse effects
  • Leukotriene Antagonists / pharmacokinetics
  • Male
  • Middle Aged
  • Quinolines / administration & dosage*
  • Quinolines / adverse effects
  • Quinolines / pharmacokinetics
  • Salmeterol Xinafoate
  • Sulfides

Substances

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