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+Olodaterol Fixed Dose Combination Delivered by the Respimat® Inhaler vs. 6 Weeks Twice Daily Treatment With Fluticasone Propionate+Salmeterol Fixed Dose Combination Delivered by the Accuhaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 229
- Locations
- 29
- Primary Endpoint
- FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment
Study Overview
Brief Summary
The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC [2.5/ 5µg and 5/ 5µg] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC [250/50µg and 500/50µg] delivered by the Accuhaler® after 6 weeks of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
T+O FDC dosage 1
Low dose
Intervention: placebo (Drug)
ICS/LABA FDC Dosage 1
Low dose
Intervention: placebo (Drug)
T+O FDC dosage 2
High dose
Intervention: placebo (Drug)
ICS/LABA FDC Dosage 2
High dose
Intervention: placebo (Drug)
T+O FDC dosage 1
Low dose
Intervention: olodaterol (Drug)
T+O FDC dosage 1
Low dose
Intervention: tiotropium (Drug)
ICS/LABA FDC Dosage 1
Low dose
Intervention: fluticasone propionate (Drug)
T+O FDC dosage 2
High dose
Intervention: tiotropium (Drug)
T+O FDC dosage 2
High dose
Intervention: olodaterol (Drug)
ICS/LABA FDC Dosage 1
Low dose
Intervention: salmeterol (Drug)
ICS/LABA FDC Dosage 2
High dose
Intervention: fluticasone propionate (Drug)
ICS/LABA FDC Dosage 2
High dose
Intervention: salmeterol (Drug)
Outcomes
Primary Outcomes
FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment
Time Frame: Baseline and 6 weeks.
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) \[L\] after 6 weeks of treatment. Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
Secondary Outcomes
- FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment(Baseline and 6 weeks.)
- Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment(Baseline and 6 weeks.)
- FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment(Baseline and 6 weeks.)
- FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment(Baseline and 6 weeks.)