Document Detail

Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period.
MedLine Citation:
PMID:  14616102     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Proinflammatory mediators such as the cysteinyl leukotrienes are important in the pathophysiology of allergic rhinitis. This study evaluated the efficacy and tolerability of montelukast, a cysteinyl leukotriene receptor antagonist, given once daily in the morning for treatment of seasonal (fall) allergic rhinitis for 4 weeks. METHODS: This was a randomized, double-blind trial with a placebo run-in and a 4-week treatment period. Patients (n = 1079) with a history of allergic rhinitis and a positive skin test to seasonal pollen allergens were assigned to placebo, montelukast 10 mg, or loratadine 10 mg. Symptoms were assessed with a daily diary. RESULTS: Montelukast was more effective than placebo in improving scores for the primary endpoint of daytime nasal symptoms (P = 0.003) and the secondary endpoints of night-time, composite, and daytime eye symptoms, patient's and physician's global evaluations of allergic rhinitis, and rhinoconjunctivitis quality-of-life (P </= 0.006). The positive control loratadine also improved scores for the primary endpoint (P </= 0.001) and the majority of the secondary endpoints (P < 0.03). When analyzed by week, the treatment effect of montelukast was more persistent than loratadine over all 4 weeks of treatment. CONCLUSION: Montelukast provided effective relief of seasonal allergic rhinitis symptoms when given once daily in the morning, showed significant and sustained improvement in symptoms of allergic rhinitis over 4 weeks of treatment, and was well-tolerated.
J van Adelsberg; G Philip; A J Pedinoff; E O Meltzer; P H Ratner; J Menten; T F Reiss;
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Allergy     Volume:  58     ISSN:  0105-4538     ISO Abbreviation:  Allergy     Publication Date:  2003 Dec 
Date Detail:
Created Date:  2003-11-17     Completed Date:  2004-04-14     Revised Date:  2009-10-12    
Medline Journal Info:
Nlm Unique ID:  7804028     Medline TA:  Allergy     Country:  Denmark    
Other Details:
Languages:  eng     Pagination:  1268-76     Citation Subset:  IM    
Merck Research Laboratories, Rahway, NJ, USA.
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MeSH Terms
Acetates / therapeutic use*
Anti-Allergic Agents / therapeutic use
Double-Blind Method
Leukotriene Antagonists / therapeutic use*
Loratadine / therapeutic use
Middle Aged
Quinolines / therapeutic use*
Rhinitis, Allergic, Seasonal / drug therapy*
Treatment Outcome
Reg. No./Substance:
0/Acetates; 0/Anti-Allergic Agents; 0/Leukotriene Antagonists; 0/Quinolines; 158966-92-8/montelukast; 79794-75-5/Loratadine
Erratum In:
Allergy. 2004 Mar;59(3):357
Allergy. 2009 Nov;64(11):1697

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