Efficacy and safety of azelastine 0.15% nasal spray administered once daily in subjects with seasonal allergic rhinitis.

Abstract

Azelastine nasal spray is commercially available as a 0.1% w/v solution and is recommended for twice-daily dosing. Increasing the azelastine concentration to 0.15% may be effective with once-daily dosing without increasing the incidence of adverse events. This study evaluated the efficacy and safety of azelastine 0.15% nasal spray at a dosage of 2 sprays/nostril once daily. This randomized, double-blind, placebo-controlled study was conducted in subjects with moderate-to-severe seasonal allergic rhinitis (SAR) during the 2007/2008 Texas Mountain Cedar season. In total, 536 subjects were randomized to 2 sprays/nostril once daily (A.M.) of azelastine 0.15% or placebo. The primary efficacy variable was change from baseline in a 12-hour reflective Total Nasal Symptom Score (TNSS), consisting of nasal congestion, runny nose, itchy nose, and sneezing. The key secondary variable was change from baseline in 24-hour instantaneous TNSS, which determines the duration of action and effective dosing interval. After 2 weeks, the mean improvement in 12-hour reflective TNSS and percentage improvement in 12-hour reflective TNSS were significant (p < 0.001) with azelastine 0.15% (19%) compared with placebo (10%). The improvement in 24-hour instantaneous TNSS also was significant (p < 0.001) for azelastine 0.15% compared with placebo, supporting efficacy with once-daily dosing. All individual TNSS symptoms were significantly (p < 0.01) improved with azelastine 0.15% compared with placebo. With the exception of bitter taste (4.5%) and nasal discomfort (4.5%), adverse events with azelastine 0.15% were reported with an incidence similar to placebo. Azelastine 0.15% nasal spray was effective and well tolerated in subjects with SAR with once-daily dosing.

• Authors: Julius van Bavel, William C Howland, N J Amar, William Wheeler, Harry Sacks
• Journal: Allergy and asthma proceedings (Allergy Asthma Proc) 2009 Sep-Oct Vol. 30 Issue 5 Pg. 512-8 ISSN: 1539-6304 [Electronic] United States
• PMID: 19747429 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Allergic Agents
• Histamine H1 Antagonists, Non-Sedating
• Phthalazines
• azelastine

Topics

• Administration, Intranasal
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anti-Allergic Agents (administration & dosage, adverse effects)
• Child
• Double-Blind Method
• Female
• Histamine H1 Antagonists, Non-Sedating (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Phthalazines (administration & dosage, adverse effects)
• Rhinitis, Allergic, Seasonal (drug therapy, immunology)
• Treatment Outcome
• Young Adult