By Maggie Schwarz
WASHINGTON, DC -- March 16, 2009 - Total seasonal allergic rhinitis score improves significantly over 14 days with azelastine 0.15% nasal spray, according to a study presented here at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
Julius Van Bavel, MD, Allergy and Asthma Associates, Austin, Texas, and colleagues evaluated a 0.15% azelastine hydrochloride solution, 2 sprays in each nostril once daily in 536 patients with moderate to severe seasonal allergic rhinitis during the 2007-2008 Texas Mountain Cedar season.
The investigators hypothesised that increasing the azelastine concentration from 0.1% to 0.15% would allow for once-daily dosing without increasing the incidence of adverse effects, Dr. Van Bavel said in a presentation on March 15.
The 0.15% formulation of azelastine is delivered in a sorbitol-based vehicle with sucralose as a taste-masking agent.
For their study, Dr. Van Bavel and colleagues randomised patients to azelastine or placebo once daily in the morning over a 14-day period and assessed the change from baseline in the 12-hour reflective Total Nasal Symptom Score (TNSS). The score consists of nasal congestion, sneezing, itchy nose, and runny nose.
After 2 weeks of treatment, mean improvement score and percentage improvement score were statistically significant with azelastine 0.15% compared with placebo (19% vs 10%, P < .001).
Mean improvement and percentage improvement scores were also statistically significant for azelastine 0.15% compared with placebo for instantaneous morning TNSS, which indicates efficacy with once-daily dosing (P < .001).
All individual symptoms of the TNSS were significantly improved with azelastine 0.15% compared with placebo (P < .01). With the exception of dysgeusia (4.5%) and nasal discomfort (4.5%), all other adverse events were reported at a similar incidence as placebo.
Dr. Van Bavel concluded that azelastine 0.15% was effective and well tolerated with once-daily dosing and might improve patients' compliance with nasal spray therapy.
Funding for this study was provided by Meda Pharmaceuticals.
[Presentation title: Efficacy and Safety of Azelastine (0.15%) Nasal Spray Administered Once Daily in Patients With Seasonal Allergic Rhinitis. Abstract 492]
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