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Alise Reicin, MD; Richard White, MD; Steven F. Weinstein, MD; Albert F. Finn, Jr, MD; Ha Nguyen, PhD; Iza Peszek, PhD; Lori Geissler, BS; Beth C. Seidenberg, MD; for the Montelukast/Loratadine Study Group

Arch Intern Med. 2000;160:2481-2488.

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 (H₁)-receptor antagonist, has demonstrated antiallergic properties. Leukotriene-receptor antagonists given concomitantly with H₁-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 (FEV₁) 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 FEV₁) was 4.15% (95% confidence interval, 1.65%-6.65%). Key secondary end points (mean daily -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.

From the Departments of Pulmonary/Immunology (Drs Reicin and Seidenberg and Ms Geissler) and Biostatistics (Drs Nguyen and Peszek), Merck Research Laboratories, Rahway, NJ; the Division of General Medicine and Rheumatology, University of California–Davis, Sacramento (Dr White); Allergy and Asthma, Huntington Beach, Calif (Dr Weinstein); and Allergy and Asthma Centers of Charleston, PA, North Charleston, SC (Dr Finn).

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