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): 1222.51.01079 Boehringer Ingelheim Investigational Site
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Tamarac, Florida, United States
1222.51.01076 Boehringer Ingelheim Investigational Site
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Austell, Georgia, 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
1222.51.01086 Boehringer Ingelheim Investigational Site
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Lawrenceville, Georgia, United States
1222.51.01019 Boehringer Ingelheim Investigational Site
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Coeur d'Alene, Idaho, United States
1222.51.01057 Boehringer Ingelheim Investigational Site
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Duluth, Georgia, United States
1222.51.01087 Boehringer Ingelheim Investigational Site
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Jasper, Alabama, United States
1222.51.01055 Boehringer Ingelheim Investigational Site
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Florence, Alabama, United States
1222.51.01069 Boehringer Ingelheim Investigational Site
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Scottsdale, Arizona, United States
1222.51.01064 Boehringer Ingelheim Investigational Site
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Encinitas, California, United States
1222.51.01084 Boehringer Ingelheim Investigational Site
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Lincoln, California, United States
1222.51.01060 Boehringer Ingelheim Investigational Site
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Fullerton, California, United States
1222.51.01040 Boehringer Ingelheim Investigational Site
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Anaheim, California, United States
1222.51.01015 Boehringer Ingelheim Investigational Site
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Torrance, California, United States
1222.51.01052 Boehringer Ingelheim Investigational Site
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Boulder, Colorado, United States
1222.51.01006 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
1222.51.01010 Boehringer Ingelheim Investigational Site
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Wheat Ridge, Colorado, United States
1222.51.01021 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
1222.51.01042 Boehringer Ingelheim Investigational Site
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Wheat Ridge, Colorado, United States
1222.51.01070 Boehringer Ingelheim Investigational Site
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Stamford, Connecticut, United States
1222.51.01082 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
1222.51.01065 Boehringer Ingelheim Investigational Site
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DeLand, Florida, United States
1222.51.01051 Boehringer Ingelheim Investigational Site
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Jacksonville, Florida, United States
1222.51.01092 Boehringer Ingelheim Investigational Site
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Jacksonville, Florida, United States
1222.51.01081 Boehringer Ingelheim Investigational Site
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Ormond Beach, Florida, United States
1222.51.01054 Boehringer Ingelheim Investigational Site
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Panama City, Florida, United States
1222.51.01088 Boehringer Ingelheim Investigational Site
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Port Orange, Florida, United States
1222.51.01062 Boehringer Ingelheim Investigational Site
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Pensacola, Florida, United States
1222.51.01075 Boehringer Ingelheim Investigational Site
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Atlanta, Georgia, United States
1222.51.01027 Boehringer Ingelheim Investigational Site
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Eagle, Idaho, United States
1222.51.01048 Boehringer Ingelheim Investigational Site
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Arlingron Heights, Illinois, United States
1222.51.01044 Boehringer Ingelheim Investigational Site
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River Forest, Illinois, United States
1222.51.01043 Boehringer Ingelheim Investigational Site
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Skokie, Illinois, United States
1222.51.01023 Boehringer Ingelheim Investigational Site
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Lafayette, Louisiana, United States
1222.51.01071 Boehringer Ingelheim Investigational Site
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Opelousas, Louisiana, United States
1222.51.01050 Boehringer Ingelheim Investigational Site
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North Dartmouth, Massachusetts, United States
1222.51.01025 Boehringer Ingelheim Investigational Site
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Livonia, Michigan, United States
1222.51.01078 Boehringer Ingelheim Investigational Site
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Edina, Minnesota, United States
1222.51.01033 Boehringer Ingelheim Investigational Site
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Fridley, Minnesota, United States
1222.51.01074 Boehringer Ingelheim Investigational Site
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St. Charles, Missouri, United States
1222.51.01037 Boehringer Ingelheim Investigational Site
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St. Louis, Missouri, United States
1222.51.01039 Boehringer Ingelheim Investigational Site
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Reno, Nevada, United States
1222.51.01045 Boehringer Ingelheim Investigational Site
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Larchmont, New York, United States
1222.51.01014 Boehringer Ingelheim Investigational Site
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Asheville, North Carolina, United States
1222.51.01018 Boehringer Ingelheim Investigational Site
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Rochester, New York, United States
1222.51.01056 Boehringer Ingelheim Investigational Site
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Greensboro, North Carolina, United States
1222.51.01077 Boehringer Ingelheim Investigational Site
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Charlotte, North Carolina, United States
1222.51.01011 Boehringer Ingelheim Investigational Site
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Cincinnati, Ohio, United States
1222.51.01032 Boehringer Ingelheim Investigational Site
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Canton, Ohio, United States
1222.51.01005 Boehringer Ingelheim Investigational Site
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Columbus, Ohio, United States
1222.51.01093 Boehringer Ingelheim Investigational Site
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Dayton, Ohio, United States
1222.51.01080 Boehringer Ingelheim Investigational Site
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Toledo, Ohio, United States
1222.51.01089 Boehringer Ingelheim Investigational Site
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Sylvania, Ohio, United States
1222.51.01031 Boehringer Ingelheim Investigational Site
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Corvallis, Oregon, United States
1222.51.01047 Boehringer Ingelheim Investigational Site
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Tulsa, Oklahoma, United States
1222.51.01020 Boehringer Ingelheim Investigational Site
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Medford, Oregon, United States
1222.51.01016 Boehringer Ingelheim Investigational Site
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Erie, Pennsylvania, United States
1222.51.01004 Boehringer Ingelheim Investigational Site
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Philadelphia, Pennsylvania, United States
1222.51.01009 Boehringer Ingelheim Investigational Site
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Johnston, Rhode Island, United States
1222.51.01030 Boehringer Ingelheim Investigational Site
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East Providence, Rhode Island, United States
1222.51.01061 Boehringer Ingelheim Investigational Site
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Columbia, South Carolina, United States
1222.51.01046 Boehringer Ingelheim Investigational Site
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Easley, South Carolina, United States
1222.51.01038 Boehringer Ingelheim Investigational Site
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Easley, South Carolina, United States
1222.51.01022 Boehringer Ingelheim Investigational Site
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Gaffney, South Carolina, United States
1222.51.01063 Boehringer Ingelheim Investigational Site
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Greenville, South Carolina, United States
1222.51.01013 Boehringer Ingelheim Investigational Site
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Greer, South Carolina, United States
1222.51.01024 Boehringer Ingelheim Investigational Site
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Spartanburg, South Carolina, United States
1222.51.01012 Boehringer Ingelheim Investigational Site
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Union, South Carolina, United States
1222.51.01008 Boehringer Ingelheim Investigational Site
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Rapid City, South Dakota, United States
1222.51.01035 Boehringer Ingelheim Investigational Site
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Johnson City, Tennessee, United States
1222.51.01083 Boehringer Ingelheim Investigational Site
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Corsicana, Texas, United States
1222.51.01028 Boehringer Ingelheim Investigational Site
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Boerne, Texas, United States
1222.51.01085 Boehringer Ingelheim Investigational Site
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Killeen, Texas, United States
1222.51.01073 Boehringer Ingelheim Investigational Site
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Longview, Texas, United States
1222.51.01058 Boehringer Ingelheim Investigational Site
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Murray, Utah, United States
1222.51.01068 Boehringer Ingelheim Investigational Site
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Abingdon, Virginia, United States
1222.51.01091 Boehringer Ingelheim Investigational Site
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Spokane, Washington, United States
1222.51.01002 Boehringer Ingelheim Investigational Site
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Vancouver, Washington, United States
1222.51.01001 Boehringer Ingelheim Investigational Site
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Morgantown, West Virginia, United States
1222.51.01066 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
1222.51.01017 Boehringer Ingelheim Investigational Site
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Oklahoma City, Oklahoma, United States
1222.51.01053 Boehringer Ingelheim Investigational Site
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Portland, Oregon, United States
1222.51.01003 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, United States
1222.51.01090 Boehringer Ingelheim Investigational Site
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Louisville, Kentucky, United States
1222.51.01049 Boehringer Ingelheim Investigational Site
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Ann Arbor, Michigan, United States
1222.51.01036 Boehringer Ingelheim Investigational Site
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Charleston, South Carolina, United States
1222.51.01029 Boehringer Ingelheim Investigational Site
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Richmond, Virginia, United States
1222.51.01034 Boehringer Ingelheim Investigational Site
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Richmond, Virginia, United States
1222.51.01072 Boehringer Ingelheim Investigational Site
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Richmond, Virginia, United States