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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR ASTELIN

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Clinical Trials for Astelin

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

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Clinical Trial Conditions for Astelin

Condition Name

Condition Name for Astelin
Intervention Trials
Seasonal Allergic Rhinitis 3
Allergic Rhinitis 1
Vasomotor Rhinitis 1
Nonallergic Rhinitis 1
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Condition MeSH

Condition MeSH for Astelin
Intervention Trials
Rhinitis 6
Rhinitis, Allergic 5
Rhinitis, Allergic, Seasonal 3
Common Cold 1
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Clinical Trial Locations for Astelin

Trials by Country

Trials by Country for Astelin
Location Trials
United States 25
Canada 1
Germany 1
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Trials by US State

Trials by US State for Astelin
Location Trials
Texas 3
New Jersey 2
Pennsylvania 1
South Carolina 1
Tennessee 1
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Clinical Trial Progress for Astelin

Clinical Trial Phase

Clinical Trial Phase for Astelin
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Astelin
Clinical Trial Phase Trials
Completed 6
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Clinical Trial Sponsors for Astelin

Sponsor Name

Sponsor Name for Astelin
Sponsor Trials
Meda Pharmaceuticals 3
ClinResearch, GmbH 1
Alcon Research 1
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Sponsor Type

Sponsor Type for Astelin
Sponsor Trials
Industry 7
Other 1
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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
Teva
Fish and Richardson
Harvard Business School
Argus Health
Cipla
Express Scripts
Johnson and Johnson

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