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Montelukast improves symptoms of seasonal allergic rhinitis over a 4‐week treatment period
Author(s) -
Van Adelsberg J.,
Philip G.,
Pedinoff A. J.,
Meltzer E. O.,
Ratner P. H.,
Menten J.,
Reiss T. F.
Publication year - 2003
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1046/j.1398-9995.2003.00261.x
Subject(s) - montelukast , medicine , loratadine , placebo , tolerability , morning , asthma , leukotriene receptor , clinical endpoint , randomized controlled trial , anesthesia , adverse effect , alternative medicine , pathology
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.