Efficacy and Safety of Azelastine Hydrocloride and Fluticasone Propionate Combined in a Single Nasal Spray Delivery Device in Patients with Seasonal Allergic Rhinitis

Abstract

RATIONALE: A proof of concept study in patients with SAR indicated that combination therapy with commercially available azelastine nasal spray and commercially available fluticasone nasal spray significantly improved nasal symptoms compared to either agent alone. As a result, the current study was conducted with the combination of azelastine and fluticasone administered in a single delivery device.METHODS: The study was a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe SAR conducted during the 2007/2008 Texas Mountain Cedar season. A total of 610 patients were randomized to treatment with: (1) azelastine (Astelin) nasal spray, (2) fluticasone (Flonase) nasal spray, (3) combination azelastine/fluticasone (MP 29-02) nasal spray, or (4) placebo nasal spray. All treatments were given 1 spray per nostril twice daily. The primary efficacy variable was the change from baseline in the 12-hour reflective total nasal symptom score (TNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose.RESULTS: All three active groups were statistically superior (P < .05) to placebo, and the combination was statistically superior (P < .001) to either agent alone. The TNSS improved 31.3% with combination azelastine/fluticasone, 20.8% with fluticasone, 16.3% with azelastine, and 9.0% with placebo. Dysgeusia (7.2%), epistaxis (3.9%), and headache (2.6%) were the only adverse events reported by more than 2% of patients treated with combination therapy.CONCLUSIONS: Therapy with azelastine nasal spray and fluticasone nasal spray in combination provided significant clinical benefit compared to either agent alone. Providing the two drugs in a single delivery device should benefit patients who require combination therapy to effectively manage their allergic rhinitis. RATIONALE: A proof of concept study in patients with SAR indicated that combination therapy with commercially available azelastine nasal spray and commercially available fluticasone nasal spray significantly improved nasal symptoms compared to either agent alone. As a result, the current study was conducted with the combination of azelastine and fluticasone administered in a single delivery device. METHODS: The study was a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe SAR conducted during the 2007/2008 Texas Mountain Cedar season. A total of 610 patients were randomized to treatment with: (1) azelastine (Astelin) nasal spray, (2) fluticasone (Flonase) nasal spray, (3) combination azelastine/fluticasone (MP 29-02) nasal spray, or (4) placebo nasal spray. All treatments were given 1 spray per nostril twice daily. The primary efficacy variable was the change from baseline in the 12-hour reflective total nasal symptom score (TNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. RESULTS: All three active groups were statistically superior (P < .05) to placebo, and the combination was statistically superior (P < .001) to either agent alone. The TNSS improved 31.3% with combination azelastine/fluticasone, 20.8% with fluticasone, 16.3% with azelastine, and 9.0% with placebo. Dysgeusia (7.2%), epistaxis (3.9%), and headache (2.6%) were the only adverse events reported by more than 2% of patients treated with combination therapy. CONCLUSIONS: Therapy with azelastine nasal spray and fluticasone nasal spray in combination provided significant clinical benefit compared to either agent alone. Providing the two drugs in a single delivery device should benefit patients who require combination therapy to effectively manage their allergic rhinitis.