Clinical benefits of combination treatment with mometasone furoate nasal spray and loratadine vs monotherapy with mometasone furoate in the treatment of seasonal allergic rhinitis.

BACKGROUND: Intranasal corticosteroids and nonsedating antihistamines are the drug classes most often prescribed to treat allergic rhinitis (AR). Treatment guidelines recommend a combination of these agents for moderate-to-severe AR. However, clinical studies have found that combining an antihistamine with an intranasal corticosteroid provides few or no advantages over monotherapy with an intranasal corticosteroid.

OBJECTIVE: To compare the efficacy of mometasone furoate nasal spray (NS) plus loratadine with that of monotherapy with the individual agents in patients 12 years and older with at least a 2-year history of seasonal AR.

METHODS: In a multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study, 702 patients were randomized to receive mometasone furoate NS, 200 microg, plus loratadine, 10 mg (n = 169); mometasone furoate NS, 200 microg (n = 176); loratadine, 10 mg (n = 181); or placebo (n = 176) once daily for 15 days. Primary efficacy variables were total nasal symptom score (TNSS) and total symptom score (TSS) as recorded on diary cards.

RESULTS: No statistically significant differences were observed between mometasone furoate NS plus loratadine and mometasone furoate NS monotherapy for the primary efficacy variables. For TNSS and TSS, all 3 active drug therapies were more effective than placebo (P < or = .02). Both mometasone furoate NS treatment regimens were more effective than loratadine or placebo for TNSS (P < .01 for both) and TSS (P < or = .03 for both), whereas loratadine was more effective than placebo for TNSS only (P = .02).

CONCLUSIONS: Combination therapy with mometasone furoate NS and loratadine provided benefits similar to monotherapy with mometasone furoate NS for the symptoms of seasonal AR. Therefore, mometasone furoate NS monotherapy was shown to be an effective treatment for seasonal AR.