Completed
PHASE3
INTERVENTIONAL
NCT01696058
Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.
Interventions
Name:
Tiotropium
Type:
DRUG
Description:
marketed product
Name:
Placebo matching Olodaterol
Type:
DRUG
Description:
one dose
Name:
Tiotropium
Type:
DRUG
Description:
marketed product
Name:
Olodaterol
Type:
DRUG
Description:
one dose
Primary Outcomes
Measure:
FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12
TimeFrame:
baseline and 12 weeks
Description:
FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12. AUC was standardized by dividing by time unit.
Measure:
Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12
TimeFrame:
baseline and 12 weeks
Description:
Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12
Trial Information
NCT ID
NCT01696058
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Boehringer Ingelheim
Last Updated
December 15, 2025