Mometasone furoate nasal spray in the treatment of perennial non-allergic rhinitis: A Nordic, multicenter, randomized, double-blind, placebo-controlled study

In order to evaluate the efficacy and safety of mometasone furoate nasal sp ray (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 i n Norway). A total of 329 patients (age 18-82 years) with a mean duration o f PNAR of 9 years were included in the study. The total duration of the stu dy was I I weeks: 2 weeks of screening, 6 weeks of treatment and 3 weeks of follow-up. Inclusion criteria were unspecific rhinitis symptoms and exclus ion criteria were a positive skin prick test as well as intolerance to aspi rin or non-steroidal anti-inflammatory drugs. Endoscopy was performed to ex clude patients with structural anomalies and nasal polyps. The primary effi cacy 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 corre sponding figures were 58% and 47%. Stratifying for groups of patients havin g moderate symptoms, the results were 54% vs 43% in the ITT group and 56% v s 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 infectio ns and headache being the most frequently reported, but there was no statis tically significant difference between MFNS and placebo. The results of thi s study indicate that MFNS is a safe and effective treatment for patients w ith PNAR.