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Clinical trials for tiotropium/olodaterol

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   43861   clinical trials with a EudraCT protocol, of which   7283   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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    19 result(s) found for: tiotropium/olodaterol. Displaying page 1 of 1.
    EudraCT Number: 2014-002275-28 Sponsor Protocol Number: 1237.19 Start Date*: 2014-11-18
    Sponsor Name:Boehringer Ingelheim Finland Ky
    Full Title: A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compar...
    Medical condition: chronic obstructive pulmonary disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) IT (Completed) SE (Completed) PT (Completed) DK (Completed) BE (Completed) NL (Completed) HU (Completed) GB (Completed) ES (Completed) AT (Completed) IE (Completed) LT (Completed) CZ (Completed) LV (Completed) SK (Completed) DE (Completed) SI (Completed) GR (Completed) BG (Completed) HR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-001037-41 Sponsor Protocol Number: RPL554-CO-204 Start Date*: 2018-09-04
    Sponsor Name:Verona Pharma plc
    Full Title: A PHASE II, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, THREE WAY CROSSOVER STUDY TO ASSESS THE BRONCHODILATOR EFFECT OF RPL554 ADMINISTERED IN ADDITION TO OPEN LABEL TIOTROPIUM/OLODATEROL IN PAT...
    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: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-001719-21 Sponsor Protocol Number: 1237-0095 Start Date*: 2019-12-23
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A randomized, double blind, placebo-controlled, multi-center, parallel group study to compare the efficacy of inhaled tiotropium + olodaterol, fixed dose combination (5μg/5μg) vs. placebo delivered...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-004710-42 Sponsor Protocol Number: 1237.20 Start Date*: 2012-04-23
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination...
    Medical condition: Patients with 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) NL (Completed) DK (Completed) BE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2015-003879-29 Sponsor Protocol Number: 1237.49 Start Date*: 2015-12-30
    Sponsor Name:Boehringer Ingelheim Finland Ky
    Full Title: A 4-week, randomised, double-blind, parallel group study to evaluate the efficacy and safety of tiotropium + olodaterol fixed dose combination (5/5 µg) delivered by the Respimat® inhaler versus the...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) AT (Completed) SI (Completed) DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-002264-24 Sponsor Protocol Number: 1237.26 Start Date*: 2013-11-14
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium+ oldaterol fixed...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) SK (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2011-004253-11 Sponsor Protocol Number: 1237.15 Start Date*: 2012-01-11
    Sponsor Name:Boehringer Ingelheim Finland Ky
    Full Title: A randomised, double-blind, placebo-controlled, parallel group study to determine the effect of 12 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg, 5/5 µ...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) HU (Completed) ES (Completed) IE (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-002243-29 Sponsor Protocol Number: 1237.25 Start Date*: 2013-10-18
    Sponsor Name:Boehringer Ingelheim Ky
    Full Title: A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fix...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GB (Completed) CZ (Completed) ES (Completed) DK (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-010668-40 Sponsor Protocol Number: 1237.5 Start Date*: 2011-07-29
    Sponsor Name:Boehringer Ingelheim bv [...]
    1. Boehringer Ingelheim bv
    2. Boehringer Ingelheim bv
    Full Title: A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 μg / 5 μ...
    Medical condition: Patients with Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) FI (Completed) PT (Completed) SI (Completed) CZ (Completed) DE (Completed) HU (Completed) DK (Completed) EE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000808-41 Sponsor Protocol Number: 1237.11 Start Date*: 2013-08-27
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: Randomized, double-blind, double-dummy, active-controlled, 4 period complete cross-over study to compare the effect on lung function of 6 weeks once daily treatment with orally inhaled tiotropium+o...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed) CZ (Completed) BE (Completed) DK (Completed) SE (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-004660-30 Sponsor Protocol Number: 1237.14 Start Date*: 2012-01-18
    Sponsor Name:Boehringer Ingelheim b.v.
    Full Title: A randomised, double-blind, 5 treatment arms, 4-period, incomplete cross-over study to determine the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (F...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009032 Chronic obstructive lung disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) SE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-010669-22 Sponsor Protocol Number: 1237.6 Start Date*: 2011-09-19
    Sponsor Name: [...]
    1.
    2. Boehringer Ingelheim Norway KS
    Full Title: A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium plus olodaterol fixed dose combination (2.5 μg / ...
    Medical condition: Patients with Chronic Obstructive Pulmonary Disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038738 - Respiratory, thoracic and mediastinal disorders 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) SE (Completed) ES (Completed) SK (Completed) BE (Completed) DE (Completed) HU (Completed) IE (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-002652-32 Sponsor Protocol Number: 1237.7 Start Date*: 2013-12-10
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A randomised, placebo-controlled, double-blind, single dose, cross-over study to evaluate the efficacy and safety of orally inhaled tiotropium + olodaterol as both a fixed dose combination and a fr...
    Medical condition: Chronic Obstructive Pulmonary Disease
    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)
    Trial results: View results
    EudraCT Number: 2011-004659-37 Sponsor Protocol Number: 1237.13 Start Date*: 2012-03-01
    Sponsor Name:SCS Boehringer Ingelheim Comm.V
    Full Title: A randomised, double-blind, 5 treatment arms, 4-period, incomplete cross-over study to determine the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (F...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009032 Chronic obstructive lung disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-002974-20 Sponsor Protocol Number: 1237.28 Start Date*: 2016-08-04
    Sponsor Name:SCS Boehringer Ingelheim Comm. V
    Full Title: A randomised, double-blind, cross-over study to evaluate the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (5/5 µg) compared with tiotropium (5 µg),...
    Medical condition: Patients with moderate to severe Chronic Obstructive Pulmonary Disease according to the GOLD guidelines.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10009026 Chronic obstructive airways disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-004473-41 Sponsor Protocol Number: 2016RC22 Start Date*: 2017-03-21
    Sponsor Name:University of Dundee and NHS Tayside
    Full Title: INvestigating COPD Outcomes, Genomics and Neutrophilic Inflammation with Tiotropium and Olodaterol (INCOGNITO trial)
    Medical condition: Chronic obstructive pulmonary disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000015472 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-002671-18 Sponsor Protocol Number: 1237.16 Start Date*: 2014-04-02
    Sponsor Name:Boehringer Ingelheim Limited
    Full Title: An explorarory, 12 week, randomised, partially double-blinded, placebo-controlled parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixe...
    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: GB (Completed) DK (Completed) BE (Completed) PT (Completed) DE (Completed) AT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-002256-16 Sponsor Protocol Number: 19-01SPIOMI Start Date*: 2020-01-28
    Sponsor Name:Fraunhofer Society
    Full Title: Acute and two-week effects of Spiolto® Respimat® (Tiotropium/Olodaterol) on cardiac function, the autonomic nervous system and small airway function in hyperinflated COPD subjects
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-000585-36 Sponsor Protocol Number: 204990 Start Date*: 2016-08-08
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Randomized, Open-Label, 8-Week Cross-Over Study to Compare Umeclidinium/Vilanterol with Tiotropium/Olodaterol Once-Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
    Medical condition: Subjects with COPD
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10010952 COPD LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    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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