Effectiveness of montelukast in the treatment of cough variant asthma

Ann Allergy Asthma Immunol. 2004 Sep;93(3):232-6. doi: 10.1016/S1081-1206(10)61493-7.


Background: Antileukotriene agents have been shown to be beneficial in chronic asthma. Although patients with cough variant asthma have cough with minimal wheezing and dyspnea, airway hyperresponsiveness from chronic inflammation is believed to be the underlying mechanism.

Objective: To evaluate the effectiveness of montelukast, a leukotriene receptor antagonist, in the treatment of cough variant asthma.

Methods: Fourteen patients with cough variant asthma participated in a randomized, double-blind, placebo-controlled trial with a 7- to 10-day baseline period and a 4-week treatment period with montelukast, 10 mg, or placebo daily. Inclusion criteria were (1) chronic cough with a duration of at least 4 weeks with minimal or no wheezing or dyspnea and (2) forced expiratory volume in 1 second of 50% to 85% of predicted and reversibility of 12% with use of an inhaled beta-agonist or forced expiratory volume in 1 second greater than 85% and positive methacholine challenge results. Patients fulfilled the minimum criteria for cough frequency and symptom scores for randomization.

Results: Eight patients received montelukast and 6 received placebo. The primary efficacy variable, mean percentage change from baseline in cough frequency, was significantly improved by the second week, and by the fourth week the mean percentage change from baseline was 75.7% for the treatment group and 20.7% for the placebo group.

Conclusions: The leukotriene receptor antagonist montelukast seems to be effective in the treatment of cough variant asthma. Larger studies are recommended to confirm this effect.

Publication types

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

MeSH terms

  • Acetates / therapeutic use*
  • Adrenergic beta-Agonists / administration & dosage
  • Adrenergic beta-Agonists / therapeutic use
  • Adult
  • Aged
  • Anti-Asthmatic Agents / administration & dosage
  • Anti-Asthmatic Agents / therapeutic use*
  • Antitussive Agents / administration & dosage
  • Antitussive Agents / therapeutic use*
  • Asthma / complications
  • Asthma / drug therapy*
  • Bronchial Provocation Tests
  • Cough / drug therapy*
  • Cough / etiology
  • Cyclopropanes
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Forced Expiratory Volume / drug effects
  • Humans
  • Leukotriene Antagonists / administration & dosage
  • Leukotriene Antagonists / therapeutic use*
  • Male
  • Methacholine Chloride
  • Middle Aged
  • Monitoring, Ambulatory
  • Pilot Projects
  • Quinolines / therapeutic use*
  • Severity of Illness Index
  • Sulfides
  • Treatment Outcome


  • Acetates
  • Adrenergic beta-Agonists
  • Anti-Asthmatic Agents
  • Antitussive Agents
  • Cyclopropanes
  • Leukotriene Antagonists
  • Quinolines
  • Sulfides
  • Methacholine Chloride
  • montelukast