Onset of Action of MP29-02 in the Treatment of Seasonal Allergic Rhinitis

Abstract

RATIONALE: In that optimal treatment of seasonal allergic rhinitis (SAR) should reduce symptoms as effectively and as quickly as possible, an important objective of this study (MP 4004) was to evaluate the onset of action of MP29-02 (azelastine and fluticasone propionate [FP]) in a single nasal spray delivery device compared to azelastine, FP, and placebo nasal sprays. METHODS: A 2-week, randomized, double-blind, placebo-controlled trial was conducted in patients with SAR. The study compared the MP29-02 formulation with azelastine, 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). A clinically relevant secondary efficacy variable was onset of action, defined as sustained statistically significant superiority versus placebo in instantaneous TNSS during a 4-hour observation period. Early symptom relief was also supported by a post-hoc responder analysis of time-to-response (50% improvement in TNSS). RESULTS: Onset of action was achieved within 30 minutes for MP29-02 vs placebo. Time-to-response was statistically significantly earlier (p≤0.0497) with more responders observed for MP29-02 (53.5% vs ≤43.7%) compared to azelastine, FP, or placebo alone. CONCLUSIONS: MP29-02 may represent an important therapeutic option for patients with SAR because it has a fast onset of action and is more effective than monotherapy with a nasal antihistamine or nasal corticosteroid.