An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks
Study Overview
Brief Summary
The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
placebo
patient will receive placebo once daily, 2 puffs in the morning
Intervention: placebo to tiotropium + olodaterol (Drug)
tiotropium + olodaterol high dose with BM
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning
Intervention: tiotropium +olodaterol (Drug)
tiotropium
patient will receive tiotropium 5 mcg once daily, 2 puffs in the morning
Intervention: tiotropium (Drug)
tiotropium + olodaterol with exercise training and BM
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning
Intervention: tiotropium+olodaterol (Drug)
Outcomes
Primary Outcomes
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks
Time Frame: Week 8
Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.
Secondary Outcomes
- Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12(Week 12)
- Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment(Week 12)
- Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12(Week 12)
- Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks(Week 12)
- One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment(Week 8)
- One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment(Week 8)
- Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment(Week 8)