Tiotropium In Exercise

Boehringer Ingelheim519 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

519

Conditions

Pulmonary Disease, Chronic Obstructive Exercise

Interventions

tiotropium 18 mcgDRUG

Oral inhalation once daily of 18mcg tiotropium via handihaler

PlaceboDRUG

Oral inhalation of once-daily placebo matching tiotropium via handihaler

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion criteria 1. All patients must sign an informed consent 2. Diagnosis of COPD with specific spirometric criteria (determined at study visits) 3. Age \>= 40 years 4. Medical Research Council Dyspnoea score \>= 2 5. Current or ex-smoker with a \>= 10 pack-year smoking history 6. Ability to exercise on treadmill Exclusion criteria 1. Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment 2. Clinical history of asthma 3. Use of supplemental oxygen therapy 4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery) 5. Recent history (\<= 12 months) of myocardial infarction 6. Unstable or life-threatening cardiac arrhythmia 7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years 8. Pregnant or nursing women 9. Known hypersensitivity to anticholinergic drugs or any component of the study medications 10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1 11. Estimated life expectancy \< 2 years 12. Symptomatic prostatic hyperplasia or bladder neck obstruction 13. Known narrow-angle glaucoma 14. Any condition that is contraindicated for exercise 15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing 16. Body mass index \< 18 kg/m2 or \>35 kg/m2 list truncated for space

Locations (62)

Outcomes

Primary Outcomes

90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time frame: baseline, 96 weeks

Secondary Outcomes

90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time frame: baseline, 8 weeks

90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time frame: baseline, 16 weeks

90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time frame: baseline, 32 weeks

90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time frame: baseline, 48 weeks

90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time frame: baseline, 64 weeks

90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Data from ClinicalTrials.gov

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205.368.01023 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

205.368.01022 Boehringer Ingelheim Investigational Site

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

...and 52 more locations

Time frame: baseline, 80 weeks

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 8 weeks

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 16 weeks

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 32 weeks

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 48 weeks

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 64 weeks

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 80 weeks

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 96 weeks

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 8 weeks

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 16 weeks

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 32 weeks

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 48 weeks

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 64 weeks

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 80 weeks

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 96 weeks

Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 8 weeks

Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 16 weeks

Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 32 weeks

Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 48 weeks

Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 64 weeks

Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 80 weeks

Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 96 weeks

Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 8 weeks

Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 16 weeks

Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 32 weeks

Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 48 weeks

Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 64 weeks

Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 80 weeks

Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 96 weeks

Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Time frame: baseline, 96 weeks

Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Time frame: baseline, 96 weeks

Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase

Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

Time frame: baseline, 96 weeks

Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase

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)

Time frame: baseline, 8 weeks

Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase

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)

Time frame: baseline, 16 weeks

Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase

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)

Time frame: baseline, 32 weeks

Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase

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)

Time frame: baseline, 48 weeks

Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase

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)

Time frame: baseline, 64 weeks

Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase

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)

Time frame: baseline, 80 weeks

Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase

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)

Time frame: baseline, 96 weeks

Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase

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)

Time frame: baseline, 8 weeks

Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase

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)

Time frame: baseline, 16 weeks

Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase

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)

Time frame: baseline, 32 weeks

Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase

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)

Time frame: baseline, 48 weeks

Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase

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)

Time frame: baseline, 64 weeks

Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase

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)

Time frame: baseline, 80 weeks

Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase

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)

Time frame: baseline, 96 weeks

Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time frame: baseline, 96 weeks

Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time frame: baseline, 96 weeks

Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time frame: baseline, 96 weeks

Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time frame: baseline, 96 weeks

Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase

COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.

Time frame: baseline, 96 weeks

90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Time frame: baseline, 100 weeks

Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase

FEV1 is the maximal amount of air you can forcefully exhale in one second.

Time frame: baseline, 100 weeks

Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase

FVC is the volume of air that can be forcibly blown out after full inspiration.

Time frame: baseline, 100 weeks

Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time frame: baseline, 100 weeks

Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time frame: baseline, 100 weeks

Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time frame: baseline, 100 weeks

Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase

Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

Time frame: baseline, 100 weeks

Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status

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.

Time frame: From first drug administration until 30 days after last drug administration