Methods: This study was a 2-week randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe seasonal allergic rhinitis (SAR). It compared MP29-02 (a novel intranasal formulation of Az and FP), to Az, FP, and placebo nasal sprays alone. All treatments were administered 1 spray per nostril twice daily (AM and PM) in the same delivery device. Total daily doses of azelastine and FP in the single delivery device were 548 mcg and 200 mcg, respectively. The primary efficacy variable was change from baseline in the 12-hour reflective total nasal symptom score (TNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. Symptoms were scored twice daily on a 4-point scale (daily maximum of 24).
Results: Over the 2 weeks of treatment, the mean TNSS improvement from baseline with the MP29-02 formulation (5.54) was statistically significantly superior compared to Az (4.54; P=.032), FP (4.55; P=.038), and placebo (3.03; P<.001). Headache (3.1%) and bitter taste (2.1%) were the most commonly reported adverse events with MP29-02.
Conclusions: MP29-02 may represent an important treatment option for patients with seasonal allergic rhinitis. It was more effective than a first-line nasal antihistamine or nasal corticosteroid monotherapy and was well tolerated in treating nasal symptoms associated with SAR.