Abstract
Abstract
Background
A previous study with azelastine nasal spray in patients with seasonal allergic rhinitis (SAR) demonstrated that increasing the azelastine concentration from 0.1% to 0.15% allowed for once‐daily dosing without increasing the incidence of adverse effects. This study evaluated the efficacy of azelastine 0.15% nasal spray administered once daily for treating symptoms of SAR.
Methods
In this 14‐day, randomized, double‐blind, placebo‐controlled study, patients with moderate‐to‐severe SAR were randomized to azelastine 0.15% (n = 251) or placebo (n = 255), both at a dosage of 2 sprays/nostril once daily. The primary efficacy variable was change from baseline in the 12‐hour reflective Total Nasal Symptom Score (TNSS). Key secondary variables were change from baseline in 24‐hour instantaneous TNSS, to establish the dosing interval, and change from baseline in the Total Ocular Symptom Score (TOSS).
Results
The mean improvement (3.57) and percentage improvement (19.3%) in 12‐hour reflective TNSS was significant (p p p ≤ 0.012) with azelastine 0.15% (2.21 and 16.7%, respectively) compared to placebo (1.28 and 6.0%, respectively). The overall score for the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was significantly (p Conclusion
Azelastine 0.15% was effective and well tolerated with once‐daily dosing. Azelastine 0.15% nasal spray significantly improved a complex of eye symptoms compared to placebo. © 2011 ARS‐AAOA, LLC.