Efficacy of Leukotriene Antagonists as Concomitant Therapy in Allergic Rhinitis

Objectives/Hypothesis: The symptoms of allergic rhinitis result from an immunoglobulin E-dependent mast cell activation cascade, marked by the release of inflammatory mediators, including histamine. Patients with perennial allergic rhinitis also have elevated levels of cysteinyl leukotrienes (CysLTs) in nasal lavage fluid. Histamine and CysLTs produce different responses in the pathogenesis of allergic rhinitis, and this study tested the hypothesis that the effects of combined antihistamine and leukotriene antagonist therapy would be more effective than antihistamine alone. Study Design: Multicentered, prospective, randomized, placebo-controlled, parallel-group. Methods: Three groups totaling 275 patients using: 1) fexofenadine alone, 2) fexofenadine with montelukast, or 3) fexofenadine with placebo, participated in a 21-day trial conducted during the spring pollen season. Objective analysis included pre- and poststudy physical examination findings and nasal resistance measurements. Subjective data gathered included a daily patient diary and pre- and poststudy patient satisfaction measurements. Results: The group using both fexofenadine and montelukast showed significantly better control of nasal congestion both subjectively, using patient diary and visual analog scale evaluations, and objectively, using rhinomanometry and physical examination, compared to groups using antihistamine alone or with placebo. Conclusions: Our data provided both objective and subjective evidence that leukotriene receptor antagonist-antihistamine combination therapy is more effective than antihistamine alone in the control of allergic rhinitis symptoms.