CLINICAL TRIALS PROFILE FOR AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
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All Clinical Trials for Azelastine Hydrochloride; Fluticasone Propionate
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00651118 ↗ | A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies | Completed | Meda Pharmaceuticals | Phase 3 | 2008-03-01 | 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) |
| NCT00660517 ↗ | A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies | Completed | Meda Pharmaceuticals | Phase 3 | 2007-12-01 | 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) |
| NCT00740792 ↗ | A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies | Completed | Meda Pharmaceuticals | Phase 3 | 2008-08-01 | The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) are more effective than placebo or either medication alone (azelastine or fluticasone) |
| NCT00883168 ↗ | A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies | Completed | Meda Pharmaceuticals | Phase 3 | 2009-04-01 | 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). |
| 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 | 2010-08-01 | 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 | 2010-08-01 | 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 | >Start Date | >Summary |
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