Kansas, USA-based CyDex Pharmaceuticals presented Phase II trial results for its Captisol-Enabled budesonide/azelastine nasal spray for seasonal allergic rhinitis, demonstrating statistically-significant improvements over placebo, at the American Academy of Allergy, Asthma & Immunology annual meeting in Washington DC.
A randomized, double-blind, placebo-controlled, three-way cross-over study was conducted in 108 SAR patients to compare the relative efficacy of Captisol-Enabled Budesonide plus Azelastine Nasal Spray (Single Solution) and Rhinocort Aqua (Suspension) plus Astelin Nasal Spray (Solution) against a placebo nasal spray solution in the treatment of allergic rhinitis in an environmental exposure chamber.
Relief of all nasal symptoms was significantly greater than placebo from 20 minutes to 10 hours following administration for both Captisol and Rhinocort (p<0.0001). Onset of action of relief from itchy nose and sneezing were significantly faster at 10 minutes for Captisol compared to Rhinocort. Relief of all eye symptoms was significant from 40 minutes.
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