A Randomised, Double Blind, Parallel Group Study to Assess the Efficacy and Safety of 12 Weeks of Once Daily, Orally Inhaled, Co-administration of Olodaterol 5µg (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) Compared to Once Daily, Orally Inhaled, Co-administration of Placebo (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) in Patients With Chronic Obstructive Pulmonary Disease (COPD)[ANHELTO TM 2]
Overview
- Phase
- Phase 3
- Intervention
- Tiotropium
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1137
- Locations
- 94
- Primary Endpoint
- FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Olodaterol andTiotropium
2 puffs Olodaterol from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered
Intervention: Tiotropium
Olodaterol andTiotropium
2 puffs Olodaterol from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered
Intervention: Olodaterol
Placebo and Tiotropium
2 puffs placebo inhalation solution from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered
Intervention: Tiotropium
Placebo and Tiotropium
2 puffs placebo inhalation solution from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered
Intervention: Placebo matching Olodaterol
Outcomes
Primary Outcomes
FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12
Time Frame: baseline and 12 weeks
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.
Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12
Time Frame: baseline and 12 weeks
Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12
Secondary Outcomes
- Trough FVC Response at 12 Weeks; Defined as Change From Baseline(baseline and 12 weeks)
- Rescue Medication Usage - Percentage of Rescue Free Days(over 12 weeks)
- Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)(over 12 weeks)
- Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)(over 12 weeks)
- Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data(12 weeks)
- Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)(over 12 weeks)
- Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline(baseline and 12 weeks)
- FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline(baseline and 12 Weeks)
- Peak FVC Response at 12 Weeks; Defined as Change From Baseline(baseline and 12 weeks)