Mometasone Furoate Nasal Spray in the Treatment of Perennial Non-allergic Rhinitis: A Nordic, Multicenter, Randomized, Double-blind, Placebo-controlled Study

Abstract

In order to evaluate the efficacy and safety of mometasone furoate nasal spray (MFNS) in patients with perennial non-allergic rhinitis (PNAR) a phase III, double-blind, randomized, placebo-controlled, Nordic multicenter study was performed at 16 sites (7 in Sweden, 3 in Denmark, 3 in Finland and 3 in Norway). A total of 329 patients (age 18-82 years) with a mean duration of PNAR of 9 years were included in the study. The total duration of the study was 11 weeks: 2 weeks of screening, 6 weeks of treatment and 3 weeks of follow-up. Inclusion criteria were unspecific rhinitis symptoms and exclusion criteria were a positive skin prick test as well as intolerance to aspirin or non-steroidal anti-inflammatory drugs. Endoscopy was performed to exclude patients with structural anomalies and nasal polyps. The primary efficacy variable was the subject's total overall evaluation. In the intention-to-treat (ITT) group of patients (n = 329) the improvement rates were 56% (MFNS) and 49% (placebo). In the per-protocol (PP) group (n = 251) the corresponding figures were 58% and 47%. Stratifying for groups of patients having moderate symptoms, the results were 54% vs 43% in the ITT group and 56% vs 41% in the PP group. The therapeutic response showed greater improvement in total nasal score as recorded by the investigator in the groups treated with MFNS as compared to the placebo group (p = 0.09 [PP], p = 0.14 [ITT]). Adverse events occurred during the study, upper respiratory tract infections and headache being the most frequently reported, but there was no statistically significant difference between MFNS and placebo. The results of this study indicate that MFNS is a safe and effective treatment for patients with PNAR.