Montelukast, a leukotriene receptor antagonist, in combination with loratadine, a histamine receptor antagonist, in the treatment of chronic asthma

Arch Intern Med. 2000 Sep 11;160(16):2481-8. doi: 10.1001/archinte.160.16.2481.


Background: Montelukast sodium, a potent, oral, specific leukotriene-receptor antagonist, has demonstrated clinical efficacy in the treatment of chronic asthma. Loratadine, a selective histamine type 1 (H(1))-receptor antagonist, has demonstrated antiallergic properties. Leukotriene-receptor antagonists given concomitantly with H(1)-receptor antagonists have been shown to have additive effects in the prevention of bronchospasm in antigen-challenge models.

Objective: To determine whether montelukast plus loratadine provides improved efficacy to montelukast alone in the treatment of chronic asthma.

Methods: The efficacy of montelukast alone vs montelukast-loratadine was studied in a 10-week, multicenter, randomized, double-blind, 2 x 2 crossover study. After a 2-week placebo run-in period, patients received montelukast sodium (10 mg) plus loratadine (20 mg), or montelukast sodium (10 mg) plus placebo once daily for 2 weeks. After a 2-week placebo washout period, patients were crossed over to receive 2 weeks of the other active treatment regimen, followed by another 2-week placebo washout period.

Results: Montelukast given concomitantly with loratadine caused significant improvement in percentage of change from baseline in forced expiratory volume in 1 second (FEV(1)) compared with montelukast alone (13.86% vs 9.72%; P =.001). The average additional effect of loratadine (least square mean difference in percentage of change from baseline in FEV(1)) was 4.15% (95% confidence interval, 1.65%-6.65%). Key secondary end points (mean daily beta-agonist use, daytime and nighttime symptom scores, morning and evening peak expiratory flow rate, and the Patient Global Evaluation) all showed significant improvement with montelukast-loratadine (P<.05).

Conclusion: Montelukast-loratadine significantly improved end points of asthma control during a 2-week treatment period.

Publication types

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

MeSH terms

  • Acetates / therapeutic use*
  • Adolescent
  • Adult
  • Aged
  • Asthma / drug therapy*
  • Chronic Disease
  • Cross-Over Studies
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Histamine H1 Antagonists / therapeutic use*
  • Humans
  • Leukotriene Antagonists / therapeutic use*
  • Loratadine / therapeutic use*
  • Male
  • Middle Aged
  • Quinolines / therapeutic use*


  • Acetates
  • Histamine H1 Antagonists
  • Leukotriene Antagonists
  • Quinolines
  • Loratadine
  • montelukast