Product
Azelastine
Aliases
Azelastine Hydrochloride, Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray
Name
Astelin
INN Name
AZELASTINE HYDROCHLORIDE
FDA Approved
Yes
5 clinical trials
4 organizations
2 indications
2 documents
Indication
Allergic ConjunctivitisIndication
Allergic RhinitisClinical trial
A Phase 3, Multicenter, Randomized, Double-masked, Active Controlled Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops 0.05% in the Treatment of Chinese Seasonal Allergic Conjunctivitis PatientsStatus: Completed, Estimated PCD: 2023-11-02
Clinical trial
Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Placebo and Mometasone Furoate/Olopatadine Hydrochloride Nasal SprayStatus: Completed, Estimated PCD: 2024-02-23
Clinical trial
Randomized Multicenter Phase III Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients (HILARIA)Status: Completed, Estimated PCD: 2023-03-03
Clinical trial
A Multicenter, Randomized, Double-blind, Placebo and Active Controlled Parallel-group Trial to Assess the Efficacy and Safety of the Fixed Combination Medicinal Product Mometasone Furoate + Azelastine Hydrochloride Nasal Spray (50 + 140 mcg) in the Treatment of Seasonal Allergic RhinitisStatus: Completed, Estimated PCD: 2023-06-20
Clinical trial
An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 Years of Age) and Young Adults (18 to 24 Years of Age) With Seasonal Allergic RhinitisStatus: Terminated, Estimated PCD: 2023-09-08
Document
DailyMed Label: AstelinOrganization
Physicians Total Care, Inc.Organization
A-S Medication SolutionsOrganization
Aurobindo Pharma LimitedOrganization
Zydus Pharmaceuticals USA Inc.