Tiotropium In Exercise
- Conditions
- Pulmonary Disease, Chronic ObstructiveExercise
- Interventions
- Drug: Placebo
- Registration Number
- NCT00525512
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 519
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tiotropium 18mcg tiotropium 18 mcg Oral inhalation once daily of 18mcg tiotropium via handihaler Placebo Placebo Oral inhalation once daily of placebo matching tiotropium via handihaler
- Primary Outcome Measures
Name Time Method 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase baseline, 96 weeks Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
- Secondary Outcome Measures
Name Time Method Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase baseline, 48 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase baseline, 64 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase baseline, 48 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase baseline, 64 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase baseline, 32 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase baseline, 8 weeks Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase baseline, 32 weeks Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase baseline, 80 weeks Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase baseline, 8 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase baseline, 80 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase baseline, 96 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase baseline, 16 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase baseline, 64 weeks Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase baseline, 80 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase baseline, 32 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase baseline, 64 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase baseline, 32 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase baseline, 8 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase baseline, 16 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase baseline, 32 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase baseline, 8 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase baseline, 16 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase baseline, 16 weeks Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase baseline, 48 weeks Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase baseline, 16 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase baseline, 96 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase baseline, 48 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase baseline, 64 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase baseline, 8 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase baseline, 80 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase baseline, 96 weeks Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase baseline, 96 weeks Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase baseline, 48 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase baseline, 96 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase baseline, 32 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase baseline, 80 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase baseline, 96 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase baseline, 96 weeks Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase baseline, 8 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase baseline, 16 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase baseline, 48 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase baseline, 96 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase baseline, 16 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase baseline, 64 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase baseline, 80 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase baseline, 48 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase baseline, 96 weeks Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase baseline, 96 weeks COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.
Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase baseline, 8 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase baseline, 96 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase baseline, 32 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase baseline, 64 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase baseline, 80 weeks The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase baseline, 96 weeks Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase baseline, 96 weeks Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase baseline, 96 weeks Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase baseline, 100 weeks Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase baseline, 100 weeks FEV1 is the maximal amount of air you can forcefully exhale in one second.
Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase baseline, 100 weeks Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase baseline, 100 weeks Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status From first drug administration until 30 days after last drug administration Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase baseline, 100 weeks Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase baseline, 100 weeks FVC is the volume of air that can be forcibly blown out after full inspiration.
Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase baseline, 100 weeks Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
Trial Locations
- Locations (62)
205.368.38002 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
205.368.01008 Boehringer Ingelheim Investigational Site
🇺🇸Fort Collins, Colorado, United States
205.368.01017 Boehringer Ingelheim Investigational Site
🇺🇸Hartford, Connecticut, United States
205.368.01016 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
205.368.01023 Boehringer Ingelheim Investigational Site
🇺🇸Jasper, Alabama, United States
205.368.01021 Boehringer Ingelheim Investigational Site
🇺🇸Kansas City, Missouri, United States
205.368.38003 Boehringer Ingelheim Investigational Site
🇺🇦Dnyepropyetrovsk, Ukraine
205.368.39004 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
205.368.01004 Boehringer Ingelheim Investigational Site
🇺🇸Bay Pines, Florida, United States
205.368.34001 Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Spain
205.368.01002 Boehringer Ingelheim Investigational Site
🇺🇸Boston, Massachusetts, United States
205.368.01027 Boehringer Ingelheim Investigational Site
🇺🇸Gaffney, South Carolina, United States
205.368.55003 Boehringer Ingelheim Investigational Site
🇧🇷Goiânia, Brazil
205.368.49005 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
205.368.39002 Boehringer Ingelheim Investigational Site
🇮🇹Parma, Italy
205.368.01003 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
205.368.49003 Boehringer Ingelheim Investigational Site
🇩🇪Köln, Germany
205.368.49002 Boehringer Ingelheim Investigational Site
🇩🇪Schmallenberg, Germany
205.368.01028 Boehringer Ingelheim Investigational Site
🇺🇸Waterbury, Connecticut, United States
205.368.01025 Boehringer Ingelheim Investigational Site
🇺🇸Hazard, Kentucky, United States
205.368.88601 Chang Gung Memorial Hosp-Linkou
🇨🇳Taoyuan, Taiwan
205.368.34003 Hospital Gregorio Maranon
🇪🇸Madrid, Spain
205.368.07003 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
205.368.70005 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
205.368.01015 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
205.368.01030 Boehringer Ingelheim Investigational Site
🇺🇸Tulsa, Oklahoma, United States
205.368.49004 Boehringer Ingelheim Investigational Site
🇩🇪Freiburg/Breisgau, Germany
205.368.49001 Boehringer Ingelheim Investigational Site
🇩🇪Tübingen, Germany
205.368.38001 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
205.368.07004 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
205.368.49006 Boehringer Ingelheim Investigational Site
🇩🇪Münster, Germany
205.368.34005 Hospital Germans Trias i Pujol
🇪🇸Badalona (Barcelona), Spain
205.368.55002 Boehringer Ingelheim Investigational Site
🇧🇷Sao Paulo, Brazil
205.368.34004 Hospital Universitario VÃrgen del RocÃo
🇪🇸Sevilla, Spain
205.368.55004 Boehringer Ingelheim Investigational Site
🇧🇷Porto Alegre - RS, Brazil
205.368.34006 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
205.368.88604 Boehringer Ingelheim Investigational Site
🇨🇳Keelung, Taiwan
205.368.88602 Boehringer Ingelheim Investigational Site
🇨🇳Taichung, Taiwan
205.368.07001 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
205.368.39001 Boehringer Ingelheim Investigational Site
🇮🇹Pisa, Italy
205.368.01022 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
205.368.01029 Boehringer Ingelheim Investigational Site
🇺🇸Biddeford, Maine, United States
205.368.01024 Boehringer Ingelheim Investigational Site
🇺🇸Union, South Carolina, United States
205.368.01020 Boehringer Ingelheim Investigational Site
🇺🇸Spartanburg, South Carolina, United States
205.368.01014 Boehringer Ingelheim Investigational Site
🇺🇸Albany, New York, United States
205.368.07006 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
205.368.39006 Boehringer Ingelheim Investigational Site
🇮🇹Ferrara, Italy
205.368.70001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
205.368.70004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
205.368.70007 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
205.368.34002 Hospital de Cruces
🇪🇸Barakaldo (Bilbao), Spain
205.368.01013 Boehringer Ingelheim Investigational Site
🇺🇸North Miami Beach, Florida, United States
205.368.54001 Boehringer Ingelheim Investigational Site
🇦🇷Rosario, Argentina
205.368.54002 Boehringer Ingelheim Investigational Site
🇦🇷Vicente López, Argentina
205.368.01018 Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
205.368.07008 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
205.368.35103 Boehringer Ingelheim Investigational Site
🇵🇹Coimbra, Portugal
205.368.35102 Boehringer Ingelheim Investigational Site
🇵🇹Matosinhos, Portugal
205.368.88603 Boehringer Ingelheim Investigational Site
🇨🇳Taipei City, Taiwan
205.368.70006 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
205.368.01019 Boehringer Ingelheim Investigational Site
🇺🇸Greenville, South Carolina, United States
205.368.07005 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada