Methods: This study was a 2-week randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe seasonal allergic rhinitis (SAR). The study compared the MP29-02 formulation with Az, FP, and placebo nasal sprays alone. The primary efficacy variable was the change from baseline in the 12-hour reflective total nasal symptom score (TNSS) with four nasal symptoms scored twice daily on a 4-point scale (daily maximum 24). Clinically relevant secondary efficacy variables were onset of action, defined as sustained statistically significant superiority versus placebo in instantaneous TNSS during a 4-hour observation period, and a post-hoc responder analysis of time-to-response (50% change in TNSS).
Results: Onset of action was achieved within 30 minutes with MP29-02 vs placebo. Time-to-response was statistically significantly earlier (p ≤ 0.0497) and more responders were observed with MP29-02 (53.5% vs. ≤ 43.7%) than with either FP or placebo.
Conclusions: MP29-02 may represent an important therapeutic option for allergic rhinitis patients because it has a fast onset of action and is more effective than using a nasal antihistamine or nasal corticosteroid alone. The optimal treatment of rhinitis should reduce symptoms as effectively and as quickly as possible.