Mometasone Furoate Nasal Spray Relieves Moderate-Severe Nasal Congestion in Patients with Seasonal Allergic Rhinitis: A Responder Analysis

RATIONALE:

Nasal Congestion (NC) is the most bothersome symptom of patients with seasonal allergic rhinitis (SAR). Intranasal corticosteroids like mometasone furoate nasal spray (MFNS) are guidelines–preferred treatment for NC.

METHODS: A post-hoc cumulative responder analysis of two clinical studies where NC was the primary endpoint. Subjects ≥12 years of age with ≥2-year SAR history, positive skin test, and moderate or severe NC were randomized to MFNS or placebo in a double-blind parallel design. The primary endpoint was the change from baseline in average AM./PM. reflective NC score averaged over days 1–15. Treatment Response ranging from >0% to >90% improvement was evaluated at 10% intervals; >30% and >50% reductions were further evaluated using the Mietinnen-Nurminen method. Breslow-Day equal odds ratios test was used to justify pooling.

RESULTS: 344 MFNS-treated and 340 placebo-treated subjects were included. For the >30% response, 36.6% of MFNS-treated subjects responded compared to 19.4% of placebo-treated subjects (P<0.001). For the >50% response, 13.4% of MFNS subjects responded compared to 6.5% of placebo-treated subjects (P=0.003). Among MFNS-treated subjects, MFNS response was greater during the second week of treatment; there was no difference between AM and PM reflective NC scores, and between moderate and severe baseline NC.

CONCLUSIONS: MFNS is effective in patients with SAR and moderate-severe nasal congestion.