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


CONCLUSIONS
Montelukast-loratadine significantly improved end points of asthma control during a 2-week treatment period.
Reicin
A
A
Pulmonary/Immunology, Merck Research Laboratories, PO Box 2000, RY32-649, Rahway, NJ 07065. alise_reicin@merck.com
White
R
R
Weinstein
S F
SF
Finn
A F
AF
Nguyen
H
H
Peszek
I
I
Geissler
L
L
Seidenberg
B C
BC
D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D002908:Chronic Disease; D018592:Cross-Over Studies; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D020024:Leukotriene Antagonists / Q000627:therapeutic use*; D017336:Loratadine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000627:therapeutic use*; D013440:Sulfides
D000085:Acetates; D003521:Cyclopropanes; D006634:Histamine H1 Antagonists; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D017336:Loratadine; C093875:montelukast