Tiotropium In Exercise

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive
Exercise

Interventions: Drug: tiotropium 18 mcg
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

Inclusion Criteria

Not provided

Exclusion Criteria

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.
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.
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.
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 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)
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): 205.368.01023 Boehringer Ingelheim Investigational Site
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Jasper, Alabama, United States
205.368.01022 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
205.368.01003 Boehringer Ingelheim Investigational Site
🇺🇸
Los Angeles, California, United States
205.368.01008 Boehringer Ingelheim Investigational Site
🇺🇸
Fort Collins, Colorado, United States
205.368.01017 Boehringer Ingelheim Investigational Site
🇺🇸
Hartford, Connecticut, United States
205.368.01028 Boehringer Ingelheim Investigational Site
🇺🇸
Waterbury, Connecticut, United States
205.368.01004 Boehringer Ingelheim Investigational Site
🇺🇸
Bay Pines, Florida, United States
205.368.01013 Boehringer Ingelheim Investigational Site
🇺🇸
North Miami Beach, Florida, United States
205.368.01025 Boehringer Ingelheim Investigational Site
🇺🇸
Hazard, Kentucky, United States
205.368.01029 Boehringer Ingelheim Investigational Site
🇺🇸
Biddeford, Maine, United States
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205.368.01023 Boehringer Ingelheim Investigational Site
🇺🇸Jasper, Alabama, United States