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CLINICAL TRIALS PROFILE FOR ASTELIN

Clinical Trials for Astelin

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00660517	A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies	Completed	Meda Pharmaceuticals	Phase 3	The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
NCT00783432	Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis	Completed	Meda Pharmaceuticals	Phase 3	The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)
NCT00883168	A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies	Completed	Meda Pharmaceuticals	Phase 3	The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medication alone (azelastine or fluticasone).
NCT00940953	Compare Captisol-Enabled (CE) Budesonide + Azelastine Nasal Solution and Rhinocort Aqua + Astelin in an Environmental Exposure Chamber (EEC) Study of Allergic Rhinitis	Completed	Ligand Pharmaceuticals	Phase 2	The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide + Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.
NCT00979615	Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis	Completed	Alcon Research	Phase 4	The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).
NCT01190852	Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays	Completed	ClinResearch, GmbH	Phase 1	The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE alone; REF). The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.
NCT01190852	Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays	Completed	Prolytic GmbH	Phase 1	The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE alone; REF). The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.
Trial ID	Title	Status	Sponsor	Phase	Summary