Efficacy and safety of azelastine 0.15% nasal spray and azelastine 0.10% nasal spray in patients with seasonal allergic rhinitis

Allergy and Asthma Proceedings
Shailen ShahHarry J Sacks

Abstract

Azelastine is a second-generation antihistamine approved for treatment of allergic rhinitis. This randomized, double-blind, placebo- and active-controlled, parallel-group clinical trial evaluated the efficacy and safety of azelastine 0.15% and azelastine 0.10% nasal spray at a dosage of 2 sprays/nostril twice daily in patients with moderate-to-severe seasonal allergic rhinitis (SAR). In total, 526 patients were randomized 1:1:1 to treatment with 2 sprays/nostril twice daily of azelastine 0.15%, azelastine 0.10%, or placebo. The primary efficacy variable was change from baseline in 12-hour reflective Total Nasal Symptom Score (TNSS; A.M. and P.M. combined), consisting of nasal congestion, rhinorrhea, itchy nose, and sneezing. After 2 weeks, the mean improvement and percentage improvement in the 12-hour reflective TNSS were significant (p < 0.001) with azelastine 0.15% and azelastine 0.10% compared with placebo. In a retrospective analysis, there was a statistical difference (p = 0.047) in the mean improvement versus placebo in the 12-hour reflective TNSS with azelastine 0.15% compared with azelastine 0.10%. Onset of action with azelastine 0.15% was within 30 minutes. Bitter taste was the most common adverse event with both azela...Continue Reading

Citations

Dec 7, 2011·Current Opinion in Otolaryngology & Head and Neck Surgery·Christos Georgalas, Ljiljana Jovancevic
May 3, 2013·Allergy, Asthma, and Clinical Immunology : Official Journal of the Canadian Society of Allergy and Clinical Immunology·Anne K EllisJames H Day
May 15, 2010·Allergy, Asthma, and Clinical Immunology : Official Journal of the Canadian Society of Allergy and Clinical Immunology·Jayant M Pinto, Seema Jeswani
May 31, 2011·Otolaryngologic Clinics of North America·Thuy-Anh N Melvin, Alpen A Patel
Jul 2, 2015·American Journal of Rhinology & Allergy·William E Berger, Eli O Meltzer
Oct 31, 2015·The Journal of Laryngology and Otology·F AksoyF Yilmaz
Feb 14, 2018·International Forum of Allergy & Rhinology·Sarah K WiseMark Zacharek

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