Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: FDC of tiotropium + olodaterol
* Drug: Placebo
* Drug: Tiotropium
* Drug: Olodaterol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDC of tiotropium + olodaterol<br>Fixed Dose Combination of tiotropium + olodaterol | Drug: FDC of tiotropium + olodaterol<br>* Fixed Dose Combination of tiotropium + olodaterol<br>Drug: Placebo<br> <br> |
| Active Comparator: Free combination tiotropium + olodaterol<br> | Drug: Tiotropium<br> <br> Drug: Olodaterol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment | 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. | Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment | 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. | Day 29 | 
| Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on 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. | Day 28 |