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Clinical Trial
. 2003 Dec;58(12):1268-76.
doi: 10.1046/j.1398-9995.2003.00261.x.

Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period

J van Adelsberg  1 , G Philip, A J Pedinoff, E O Meltzer, P H Ratner, J Menten, T F Reiss; Montelukast Fall Rhinitis Study Group
Affiliations
Clinical Trial

Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period

J van Adelsberg et al. Allergy. 2003 Dec.

Erratum in

  • Allergy. 2004 Mar;59(3):357
  • Allergy. 2009 Nov;64(11):1697

Abstract

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.

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