Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

Phase 3

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Olodaterol
Drug: Placebo matching Olodaterol
Drug: Tiotropium

Registration Number: NCT01694771

Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1134

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and Tiotropium	Placebo matching Olodaterol	2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol and Tiotropium	Olodaterol	2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Olodaterol and Tiotropium	Tiotropium	2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered
Placebo and Tiotropium	Tiotropium	2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered

Primary Outcome Measures

Name	Time	Method
Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12	baseline and 12 weeks	Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12
FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12	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

Secondary Outcome Measures

Name	Time	Method
Peak FVC Response at 12 Weeks - Defined as Change From Baseline	baseline and 12 weeks	Peak FVC response at 12 weeks - defined as change from baseline.
Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline	baseline and 12 weeks	Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as changes from baseline
FVC AUC0-3h Response at 12 Weeks - Defined as Change From Baseline	baseline and 12 weeks	Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline.
Trough FVC Response at 12 Weeks- Defined as Change From Baseline	baseline and 12 weeks	Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.
Rescue Medication Usage - Percentage of Rescue Free Days	over 12 weeks	Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).
Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)	over 12 weeks	Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.
Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)	over 12 weeks	Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.
Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)	over 12 weeks	Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.

Trial Locations

Locations (90): 1222.51.01055 Boehringer Ingelheim Investigational Site
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Florence, Alabama, United States
1222.51.01087 Boehringer Ingelheim Investigational Site
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Jasper, Alabama, United States
1222.51.01066 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
1222.51.01069 Boehringer Ingelheim Investigational Site
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Scottsdale, Arizona, United States
1222.51.01040 Boehringer Ingelheim Investigational Site
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Anaheim, California, United States
1222.51.01064 Boehringer Ingelheim Investigational Site
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Encinitas, California, United States
1222.51.01060 Boehringer Ingelheim Investigational Site
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Fullerton, California, United States
1222.51.01084 Boehringer Ingelheim Investigational Site
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Lincoln, California, United States
1222.51.01041 Boehringer Ingelheim Investigational Site
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San Diego, California, United States
1222.51.01094 Boehringer Ingelheim Investigational Site
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San Diego, California, United States
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1222.51.01055 Boehringer Ingelheim Investigational Site
🇺🇸Florence, Alabama, United States