A Study to Test the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler in People With Chronic Obstructive Pulmonary Disease (COPD) Who Have Different Abilities to Inhale
NCT ID: NCT04223843
Last Updated: 2021-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
213 participants
INTERVENTIONAL
2020-01-08
2020-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Arm
Tiotropium + Olodaterol Fixed Dose Combination (FDC) via Respimat
Tiotropium + olodaterol
Oral Inhalation
Placebo Arm
Matching placebo via Respimat
Placebo
Oral Inhalation
Interventions
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Tiotropium + olodaterol
Oral Inhalation
Placebo
Oral Inhalation
Eligibility Criteria
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Inclusion Criteria
* Male or female patients, 40 years of age or older.
* All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) \>30% and \<80% of predicted normal (European Coal and Steel Community (ECSC), \[R94-1408\]); and a postbronchodilator FEV1/ Functional Residual Capacity (FVC) \<70%, at the screening visit.
* Patients must be current or ex-smokers with a smoking history of more than 10 pack years
* Patients should meet the peak inspiratory flow rate criteria (optimal or sub-optimal) at the time of randomization depending on which strata is available for inclusion in the study.
* Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
* Patients are expected to be able to perform, according to investigator's judgment, all trial related procedures including:
* Technically acceptable pulmonary function tests (spirometry)
* Use of In-Check DIAL G16 device to measure peak inspiratory flow rate.
* Inhale medication in a competent manner (in the opinion of the investigator) from the Respimat® device
* Perform technically acceptable body plethysmography measurements. This is applicable only to patients who will consent to the optional trial procedure at the selected sites.
Exclusion Criteria
* Patients who have had a chronic obstructive pulmonary disease exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to screening visit or during the screening period.
* Patients who experienced two or more moderate chronic obstructive pulmonary disease exacerbations (exacerbation that required treatment with antibiotics and/or oral corticosteroids), or one or more exacerbation leading to hospitalization within a year prior to visit 1.
* Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
* Patients taking inhaled corticosteroids (including combinations, e.g. inhaled corticosteroids / Long-Acting β2-agonist) in the 6 months prior to screening visit.
* Patients being treated with oral corticosteroid medication due to reasons other than chronic obstructive pulmonary disease exacerbation within 6 weeks prior to the screening visit.
* Patients who have completed a pulmonary rehabilitation program in the 6 weeks prior to screening visit or patients who are currently in a pulmonary rehabilitation program.
* Further criteria apply
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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SEC Lung
Andalusia, Alabama, United States
Jasper Summit Research, LLC
Jasper, Alabama, United States
Meris Clinical Research
Brandon, Florida, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Clinical Research Specialists LLC
Kissimmee, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, United States
Infinity Medical Research
North Dartmouth, Massachusetts, United States
Pulmonary Rsrch Inst of SE MI
Farmington Hills, Michigan, United States
Minnesota Lung Center and Sleep Institute
Edina, Minnesota, United States
Minnesota Lung Center
Woodbury, Minnesota, United States
Valley Regional Hospital
Claremont, New Hampshire, United States
CHEAR Center LLC
The Bronx, New York, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Bernstein Clinical Rsrch Ctr
Cincinnati, Ohio, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, United States
Carolina Medical Research
Clinton, South Carolina, United States
VitaLink Research -Gaffney
Gaffney, South Carolina, United States
Vitalink Research - Spartansburg
Spartanburg, South Carolina, United States
Diagnostics Research Group
San Antonio, Texas, United States
Klinische Forschung Berlin GbR
Berlin, , Germany
IKF Pneumologie GmbH & Co. KG
Frankfurt, , Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, , Germany
Hamburger Institut für Therapieforschung GmbH (HIT)
Hamburg, , Germany
KLB Gesundheitsforschung Lübeck GmbH
Lübeck, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2019-001719-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1237-0095
Identifier Type: -
Identifier Source: org_study_id