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Clinical trials for Azelastine

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    14 result(s) found for: Azelastine. Displaying page 1 of 1.
    EudraCT Number: 2018-001120-18 Sponsor Protocol Number: DYM Start Date*: 2019-01-17
    Sponsor Name:Stichting Pediatrisch Onderzoek Enschede
    Full Title: The protective effect of azelastine/fluticasone propionate (Dymista) on exercise-induced airway obstruction
    Medical condition: Exercise-induced airway obstruction Asthma Allergic rhinitis
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2023-000362-34 Sponsor Protocol Number: SAN-0791 Start Date*: 2023-10-12
    Sponsor Name:Lek Pharmaceuticals d.d.
    Full Title: 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 A...
    Medical condition: Seasonal Allergic Rhinitis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-005544-34 Sponsor Protocol Number: CARVIN Start Date*: 2021-02-04
    Sponsor Name:URSAPHARM Arzneimittel GmbH
    Full Title: Double-blind placebo-controlled proof-of-concept trial to demonstrate the anti-viral efficacy of different doses of azelastine in COVID-19 positive patients.
    Medical condition: Diagnosis of SARS-CoV-2 infection documented by a positive PCR test (patients do not need to suffer from COVID-19 symptoms)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-006485-20 Sponsor Protocol Number: CHANCE Start Date*: 2023-02-22
    Sponsor Name:URSAPHARM Arzneimittel GmbH
    Full Title: COVID-19: Reducing Symptoms and Hospitalization rates by use of Azelastine Nasal spray in patients suffering from COVID-19 in Early stages
    Medical condition: Diagnosis of SARS-CoV-2 infection documented by a positive PCR test (patients do not need to suffer from COVID-19 symptoms)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-004050-31 Sponsor Protocol Number: SAN-0677 Start Date*: 2022-04-04
    Sponsor Name:Lek Pharmaceuticals d.d.
    Full Title: 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 + Azelast...
    Medical condition: Seasonal allergic rhinitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004870 10039776 Seasonal allergic rhinitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2006-001510-32 Sponsor Protocol Number: MP432 Start Date*: 2006-09-01
    Sponsor Name:Meda Pharmaceuticals
    Full Title: Active-Controlled Trial of the Safety of MP03-33 in Patients with Chronic Allergic or Nonallergic Rhinitis
    Medical condition: Chronic Allergic or Nonallergic Rhinitis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10039083 LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2007-005302-44 Sponsor Protocol Number: IPR110982 Start Date*: 2008-02-07
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A randomised, double blind, 2-way crossover trial of 8 days repeat dosing with intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in subjects with seasonal allergic r...
    Medical condition: Seasonal allergic rhinitis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039776 Seasonal allergic rhinitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-001369-42 Sponsor Protocol Number: MP4002 Start Date*: 2011-03-30
    Sponsor Name:Meda Pharmaceuticals Inc.
    Full Title: Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients with Seasonal Al...
    Medical condition: treatment of seasonal allergic rhinitis
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10039776 Seasonal allergic rhinitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001370-26 Sponsor Protocol Number: MP4004 Start Date*: 2011-03-30
    Sponsor Name:Meda Pharmaceuticals Inc.
    Full Title: Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients with Seasonal Al...
    Medical condition: treatment of seasonal allergic rhinitis
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10039776 Seasonal allergic rhinitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001371-39 Sponsor Protocol Number: MP4006 Start Date*: 2011-03-30
    Sponsor Name:Meda Pharmaceuticals Inc.
    Full Title: Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray and Fluticasone Propionate Nasal Spray in the Treatment of Patients with Seasonal All...
    Medical condition: treatment of seasonal allergic rhinitis
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10039776 Seasonal allergic rhinitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001093-17 Sponsor Protocol Number: 2015RC04 Start Date*: 2016-04-22
    Sponsor Name:Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside
    Full Title: Proof of concept study to assess downstream effects of using combined intranasal fluticasone propionate plus azelastine nasal spray on asthmatic inflammation in patients with persistent asthma and ...
    Medical condition: Asthma and allergic rhinitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10001705 Allergic asthma LLT
    20.0 100000004855 10001723 Allergic rhinitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001314-34 Sponsor Protocol Number: MP4001 Start Date*: 2011-03-30
    Sponsor Name:MedPointe Pharmaceuticals
    Full Title: Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Astelin Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Subjects with Seasonal Allergic Rhinitis
    Medical condition: treatment of seasonal allergic rhinitis
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10039776 Seasonal allergic rhinitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-002865-40 Sponsor Protocol Number: BIODYMF Start Date*: 2015-12-08
    Sponsor Name:Ghent University Hospital
    Full Title: Open label two treatment half-side comparative study to analyse difference in nasal bioavailability between MP29-02 and fluticasone propionate.
    Medical condition: Subjects who need to undergo septoplasty, septorhinoplasty or functional endoscopic sinus surgery unrelated to this study.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2011-001368-23 Sponsor Protocol Number: MP4000 Start Date*: 2011-03-30
    Sponsor Name:MedPointe Pharmaceuticals
    Full Title: Active-Controlled Trial of the Safety and Tolerability of MP29-02 in Subjects with Chronic Allergic or Nonallergic Rhinitis
    Medical condition: treatment of chronic allergic or non-allergic rhinitis
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10034382 Perennial allergic rhinitis LLT
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10034383 Perennial rhinitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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