33 completed, 7 unknown, 2 withdrawn, 1 active not recruiting. 20 Phase 3, 13 Phase 4, 6 Phase 1, 6 Phase 2, 1 Early Phase 1.
Follow azelastine: new trials by email Literature Review of azelastine trials Research Report on azelastine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Thermosensitive Gel Nasal Spray With Exosomes, Azelastine, and Interferon for Acute Phase of Chronic Sinusitis Exosomes, Azelastine, and Interferon alpha-2b, Azelastine and Interferon alpha-2b, Placebo Gel Matrix - Chronic Rhinosinusitis Without Polyps | Early Phase 1 | Not yet recruiting | The First Affiliated Hospital of Xinxiang Medical College | 108 | 2026-07-01 | 2026-06-09 |
| Dymista in Chinese Adolescents Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate - Allergic Rhinitis Due to Allergens | Phase 4 | Active not recruiting | Viatris Inc. | 100 | 2026-05-08 | 2026-09-29 |
| Azelastine Allergen Chamber - Onset of Action Study Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair), Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray, Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray - Seasonal Allergic Rhinitis | Phase 2 | Completed | MEDA Pharma GmbH & Co. KG | 84 | 2023-10-30 | 2024-03-20 |
| A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection Experimental: Primary Cohort, Placebo Comparator: Primary Cohort - Placebo - COVID-19 | Phase 4 | Recruiting | University of Chicago | 280 | 2023-07-01 | 2025-11-10 |
| 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 Mometasone + Azelastine, Mometasone Furoate, Azelastine Hydrochloride - Seasonal Allergic Rhinitis | Phase 1 | Terminated | Sandoz | 38 | 2023-06-08 | 2023-09-28 |
| Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray Azelastine Hydrochloride/ Fluticasone propionate nasal spray, 'DYMISTA' NASAL SPRAY - Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | 56 | 2023-03-24 | 2023-12-28 |
| Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis. Azelastine + Mometazone, nasal spray, Momat Rhino Advance - Seasonal Allergic Rhinitis | Phase 3 | Completed | Sandoz | 472 | 2023-02-13 | 2023-08-04 |
| Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray, Mometasone Nasal Irrigation (1 mg capsule), Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation - Chronic Rhinitis | Phase 4 | Unknown | Endeavor Health | 81 | 2022-11-23 | 2023-07-28 |
| Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis Mometasone, Azelastine, Placebo - Seasonal Allergic Rhinitis | Phase 3 | Completed | Sandoz | 669 | 2022-04-04 | 2023-07-11 |
| A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects XZP-5610 Tablet (for Part A), Placebo to match XZP-5610 Tablet (for Part A), XZP-5610 Tablet (for Part B) - Nonalcoholic Steatohepatitis (NASH) | Phase 1 | Unknown | Xuanzhu Biopharmaceutical Co., Ltd. | 112 | 2021-05-31 | 2021-06-04 |
| Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients AI201901, Azelastine Hydrochloride - Allergic Rhinitis Due to Allergens | Phase 3 | Completed | Abdi Ibrahim Ilac San. ve Tic A.S. | 210 | 2021-04-20 | 2023-09-08 |
| To Investigate Drug-drug Interaction and Relative Bioavailability Between the FDC AzelastineHCL/Beclomethasone Dipropionate Nasal Spray, & Beclomethasone Dipropionate Nasal Spray in the Test Vehicle, and RinoClenil® Nasal Spray 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) - Seasonal Allergic Rhinitis | Phase 1 / Phase 2 | Completed | Humanis Saglık Anonim Sirketi | 48 | 2021-03-25 | 2023-12-13 |
| Allergic Rhinitis Combination Pharmacotherapy Efficacy Study Fluticasone Propionate, Azelastine hydrochloride and fluticasone propionate, Rupatadine - Allergic Rhinitis | Phase 4 | Withdrawn | St. Paul's Sinus Centre | 2020-12-15 | 2023-10-31 | |
| A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergic Rhinitis azelastine/fluticasone 137/50 mcg nasal spray, Dymista™ - Allergic Rhinitis | Phase 2 | Completed | Synmosa Biopharma Corp. | 136 | 2020-08-20 | 2023-09-25 |
| Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis Azelastine hydrochloride (BAYR9258), Placebo - Allergic Rhinitis | Phase 3 | Completed | Bayer | 110 | 2020-02-03 | 2022-03-25 |
| Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis Montelukast, Azelastine, Budesonide - Allergic Rhinitis | Not applicable | Unknown | Shiraz University of Medical Sciences | 66 | 2020-01-16 | 2020-09-25 |
| DYmista NAsal Spray in CHInese Patients Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT, Azelastine Hydrochloride 0.137 MG/ACTUAT, Fluticasone Propionate 0.05 MG/ACTUAT - Allergic Rhinitis | Phase 3 | Completed | MEDA Pharma GmbH & Co. KG | 900 | 2018-06-29 | 2022-02-22 |
| MP-AzeFlu Allergen Chamber - Onset of Action Study Azelastine hydrochloride + fluticasone propionate nasal spray, Placebos, fluticasone propionate nasal spray + loratadine - Seasonal Allergic Rhinitis | Phase 4 | Completed | MEDA Pharma GmbH & Co. KG | 82 | 2017-01-07 | 2022-02-22 |
| 4"S" - Seasonal Symptoms Suppression Study Xylometazoline - intranasal application, Azelastine - intranasal application, Mometasone furoate - intranasal application - Seasonal Allergic Rhinitis | Phase 4 | Unknown | Association Asthma, Bulgaria | 60 | 2015-05-01 | 2015-09-23 |
| AZELASTINE/FLUTICASONE (AZE/FLU) Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR) azelastine + fluticasone, Placebo - Allergic Rhinitis, House Dust Mite Allergy | Phase 4 | Unknown | Universitaire Ziekenhuizen KU Leuven | 45 | 2014-10-01 | 2015-12-03 |
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Rhinitis, Allergic, Seasonal (24) · Rhinitis, Allergic (14) · Rhinitis, Allergic, Perennial (5) · COVID-19 (1) · Dust Mite Allergy (1) · Hypersensitivity (1) · Non-alcoholic Fatty Liver Disease (1) · Rhinitis (1) · Rhinitis, Vasomotor (1)
Meda Pharmaceuticals (13) · MEDA Pharma GmbH & Co. KG (5) · Sandoz (3) · Alcon Research (2) · Bayer (2) · Humanis Saglık Anonim Sirketi (2) · Abdi Ibrahim Ilac San. ve Tic A.S. (1) · Apotex Inc. (1) · Association Asthma, Bulgaria (1) · AstraZeneca (1) · Endeavor Health (1) · GlaxoSmithKline (1) · Hanlim Pharm. Co., Ltd. (1) · Ligand Pharmaceuticals (1) · Padagis LLC (1)
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Lewis M Fredane, MD (5) · Christine Kolb (3) · Lewis M. Fredane, MD (3) · Brandon Baird (1) · Brian Lipworth, MD, FRCP (1) · Darin Brimhall, DO, FACP (1) · Deepen Patel, MD (1) · Dongyang Liu, Doctor (1) · Duc Tung Nguyen, Dr. (1) · DucTung Nguyen, Dr. (1)
PMID 20674829, PMID 22287431, PMID 29371864, PMID 37580498, PMID 37920410, PMID 39067509, PMID 39885937
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