Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Umeclidinium bromide

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   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    27 result(s) found for: Umeclidinium bromide. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2019-004427-20 Sponsor Protocol Number: CHHEF Start Date*: 2020-02-07
    Sponsor Name:Luis Puente Maestu
    Full Title: PHASE IV, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, CROSSOVER, PLACEBO-CONTROLLED STUDY, TO INVESTIGATE THE EFFECT OF DUAL BRONCHODILATION WITH UMECLIDINIUM VILANTEROL ON PATIENTS WITH COPD, HYPERIN...
    Medical condition: Chronic obstructive pulmonary diseases with Heart Failure with eyection ventricular ejection fraction between 35-50%
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10013108 Disease obstructive lung LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004655-75 Sponsor Protocol Number: D5970C00002 Start Date*: 2017-07-18
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Glycopyrronium/Formoterol Fumarate fixed-dose combination relative to Umeclidinium/V...
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-000883-16 Sponsor Protocol Number: 200699 Start Date*: 2014-07-03
    Sponsor Name:GlaxoSmithKline Research & Devlopment Ltd
    Full Title: A Clinical Study to Evaluate Four Doses of Umeclidinium Bromide in Combination with Fluticasone Furoate in COPD Subjects with an Asthmatic Component
    Medical condition: COPD Subjects with an Asthmatic Component
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004855 10010952 COPD LLT
    17.1 100000004855 10009028 Chronic obstructive asthma (with obstructive pulmonary disease) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) RO (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-001871-35 Sponsor Protocol Number: AC4116136 Start Date*: 2013-03-04
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: AC4116136: A multicenter, randomized, double-blind, parallelgroup study to evaluate the efficacy and safety of the addition of umeclidinium bromide Inhalation Powder (62.5mcg) once-daily to flutic...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2016-002843-40 Sponsor Protocol Number: 205832 Start Date*: 2017-02-17
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Phase IIb, 24 week, randomized, double-blind, 3 arm parallel group study, comparing the efficacy, safety and tolerability of two doses of umeclidinium bromide administered once-daily via a dry po...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-000885-23 Sponsor Protocol Number: 201315 Start Date*: 2014-07-28
    Sponsor Name:GlaxoSmithKline Research and Development
    Full Title: A Randomized, Parallel-group, Open-label Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg compared with Glycopyrronium 44 mcg in Subjects with Chronic Obstructive Pulmonary...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) ES (Completed) HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-002238-19 Sponsor Protocol Number: 200109 Start Date*: 2013-11-05
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A study to compare the addition of umeclidinium bromide (UMEC) to fluticasone furoate (FF)/vilanterol (VI), with placebo plus FF/VI in subjects with Chronic Obstructive Pulmonary Disease (COPD) ...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-004369-29 Sponsor Protocol Number: 206854 Start Date*: 2018-04-24
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a Single Inhaler (TRELEGYTM ELLIPTATM) when Compared with Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD ...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD) which may be called emphysema or chronic bronchitis.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-002239-44 Sponsor Protocol Number: 200110 Start Date*: 2013-08-20
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A study to compare the addition of umeclidinium bromide (UMEC) to fluticasone furoate (FF)/vilanterol (VI), with placebo plus FF/VI in subjects with Chronic Obstructive Pulmonary Disease (COPD) -St...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2014-000884-42 Sponsor Protocol Number: 201316 Start Date*: 2014-09-12
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Randomized, Blinded, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg compared with Tiotropium 18 mcg in Subjects with Chronic Obstructive Pu...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-000611-14 Sponsor Protocol Number: 201314 Start Date*: 2014-06-27
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A randomized, parallel group study to evaluate the effect of Umeclidinium (UMEC) added to Inhaled corticosteroid/ long-acting beta-agonist combination therapy in subjects with Chronic Obstructive P...
    Medical condition: in subjects with Chronic Obstructive Pulmonary Disease COPD
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) GR (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-001827-38 Sponsor Protocol Number: DB2116961 Start Date*: 2014-08-21
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: Study DB2116961, a multicentre, randomised, blinded, parallel group study to compare UMEC/VI (Umeclidinium/Vilanterol) in a fixed dose combination with Indacaterol plus Tiotropium in symptomatic...
    Medical condition: COPD
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) RO (Completed) HU (Completed) SK (Completed) PL (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002513-22 Sponsor Protocol Number: 201749 Start Date*: 2017-02-20
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A 24-week treatment, multi-center, randomized, double-blind, double-dummy, parallel group study to compare Umeclidinium/Vilanterol, Umeclidimium, and Salmeterol in subjects with chronic obstructive...
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) DE (Completed) FR (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000524-18 Sponsor Protocol Number: DB2116134 Start Date*: 2013-03-08
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium bromide/vilanterol compared with fluticasone propionate/salmeterol ov...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) HU (Completed) DE (Completed) DK (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-001190-16 Sponsor Protocol Number: 207626 Start Date*: 2018-05-07
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A Phase IV, 12 week, randomised, double-blind, double-dummy study to compare single inhaler triple therapy, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), with tiotropium monotherapy bas...
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-003973-24 Sponsor Protocol Number: ZEP117115 Start Date*: 2013-01-22
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A Multicenter Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily with Tiotropium 18 mcg Once Daily over 24 Weeks in Subjects with Chronic Obstructive Pulmonar...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-001304-37 Sponsor Protocol Number: 205715 Start Date*: 2016-11-09
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual co...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) ES (Completed) PL (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001532-19 Sponsor Protocol Number: 206821 Start Date*: 2018-09-11
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A randomised open-label study to compare the effectiveness of the fixed dose combination of FF/UMEC/VI (using the Connected Inhaler System) with the combination of FP/SAL plus tiotropium (without t...
    Medical condition: Inadequately controlled asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005212-14 Sponsor Protocol Number: 200812 Start Date*: 2016-04-20
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: A phase IIIB, 24-week randomised, double-blind study to compare 'closed' triple therapy (FF/UMEC/VI) with 'open' triple therapy (FF/VI + UMEC), in subjects with chronic obstructive pulmonary diseas...
    Medical condition: in subjects with chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) RO (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-002156-16 Sponsor Protocol Number: DB2114951 Start Date*: 2014-08-13
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium/vilanterol compared with fluticasone propionate/salmeterol over 12...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 05 06:49:27 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA