Azelastine
- Generic Name
- Azelastine
- Brand Names
- Astelin, Astepro, Astepro Allergy, Dymista
- Drug Type
- Small Molecule
- Chemical Formula
- C22H24ClN3O
- CAS Number
- 58581-89-8
- Unique Ingredient Identifier
- ZQI909440X
- Background
Azelastine, a phthalazine derivative, is an antihistamine available as an intranasal spray for the treatment of allergic and vasomotor rhinitis and as an ophthalmic solution for the treatment of allergic conjunctivitis. It is a racemic mixture, though there is no noted difference in pharmacologic activity between enantiomers, and was first granted FDA approv...
- Indication
Intranasal azelastine is indicated for the symptomatic treatment of seasonal allergic rhinitis in patients 5 years and older and for the symptomatic treatment of vasomotor rhinitis in patients 12 years and older. Ophthalmic azelastine solution is indicated for the treatment of itchy eyes associated with allergic conjunctivitis.
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- Associated Conditions
- Allergic Conjunctivitis (AC), Allergic Rhinitis (AR), Allergy to Tree Pollen, Atopy Keratoconjunctivitis, Blepharitis allergic, Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis, Vasomotor Rhinitis, Allergic eye disorders
- Associated Therapies
- -
Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis
- Conditions
- Interventions
- First Posted Date
- 2023-06-05
- Last Posted Date
- 2023-09-28
- Lead Sponsor
- Sandoz
- Target Recruit Count
- 38
- Registration Number
- NCT05887843
- Locations
- 🇨🇦
Sandoz Investigational Site, Toronto, Ontario, Canada
Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis
- Conditions
- Interventions
- First Posted Date
- 2022-04-05
- Last Posted Date
- 2023-07-11
- Lead Sponsor
- Sandoz
- Target Recruit Count
- 669
- Registration Number
- NCT05311475
- Locations
- 🇵🇱
Sandoz Investigative Site, Wrocław, Poland
Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients
- Conditions
- Interventions
- First Posted Date
- 2021-01-28
- Last Posted Date
- 2023-09-08
- Lead Sponsor
- Abdi Ibrahim Ilac San. ve Tic A.S.
- Target Recruit Count
- 210
- Registration Number
- NCT04729517
- Locations
- 🇹🇷
Dokuz Eylul University, Izmir, Turkey
Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis
- Conditions
- Interventions
- First Posted Date
- 2020-09-24
- Last Posted Date
- 2020-09-25
- Lead Sponsor
- Shiraz University of Medical Sciences
- Target Recruit Count
- 66
- Registration Number
- NCT04561687
- Locations
- 🇮🇷
Shiraz University of Medical Science, Shiraz, Iran, Islamic Republic of
Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays
- Conditions
- Interventions
- First Posted Date
- 2010-08-30
- Last Posted Date
- 2022-02-07
- Lead Sponsor
- MEDA Pharma GmbH & Co. KG
- Target Recruit Count
- 30
- Registration Number
- NCT01190852
- Locations
- 🇩🇪
ClinPharmCologne, Cologne, NRW, Germany
A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis
- Conditions
- First Posted Date
- 2008-02-11
- Last Posted Date
- 2012-06-05
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 70
- Registration Number
- NCT00612118
- Locations
- 🇦🇹
GSK Investigational Site, Vienna, Austria
Drug Development Updates
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