Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
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| ClinicalTrials.gov Identifier: NCT02683109 |
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Recruitment Status :
Completed
First Posted : February 17, 2016
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
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This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.
Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Disease, Chronic Obstructive | Drug: FDC of tiotropium + olodaterol Drug: Placebo Drug: Tiotropium Drug: Olodaterol | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 221 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official 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 Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD) |
| Actual Study Start Date : | March 8, 2016 |
| Actual Primary Completion Date : | January 9, 2017 |
| Actual Study Completion Date : | January 30, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
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Drug: FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol Drug: Placebo |
| Active Comparator: Free combination tiotropium + olodaterol |
Drug: Tiotropium Drug: Olodaterol |
- Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment [ Time Frame: Day 29 ]
This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5.
The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement.
- Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment [ Time Frame: Day 29 ]
This outcome measure presents trough FVC after 28 days of treatment (measurement on Day 29).
The FVC measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement for FVC.
- Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28 [ Time Frame: Day 28 ]
This outcome measure presents COPD assessment test score on Day 28. The COPD Assessment Test™ is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health).
The CAT measurement on Visit 4 prior to the first dose of double-blind study drug was the baseline for CAT.
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Male or female patients.
- Patients 40 years of age or older.
- Patients with a smoking history > 10 pack years.
- Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70% at screening.
- Symptomatic patients with CAT (COPD Assessment Test TM) score >= 10 at screening.
- Further inclusion criteria apply.
Exclusion criteria:
- COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
- Patients with a current diagnosis of asthma.
- Further exclusion criteria apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683109
Show 22 study locations
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT02683109 |
| Other Study ID Numbers: |
1237.49 2015-003879-29 ( EudraCT Number ) |
| First Posted: | February 17, 2016 Key Record Dates |
| Results First Posted: | August 17, 2018 |
| Last Update Posted: | August 17, 2018 |
| Last Verified: | December 2017 |
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Lung Diseases Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Lung Diseases, Obstructive Tiotropium Bromide Olodaterol Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Parasympatholytics Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |