Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of Tiotropium on Walking Capacity in Patients With COPD
Verified date | August 2010 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
This study was designed to test the following hypothesis:
A) The acute and long-term (3 weeks) bronchodilator-induced changes in exercise tolerance
and in the physiological response during the endurance shuttle walk will be greater with
tiotropium compared to placebo in COPD patients.
B) Three weeks of bronchodilation will be associated with increase activity of daily living
as evaluated using the London Chest Activity Daily Living scale.
Status | Completed |
Enrollment | 33 |
Est. completion date | August 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 85 Years |
Eligibility |
Inclusion Criteria: - age > 50 years, smoking history > 10 packs/year, FEV1 < 70% of predicted and FEV1/FVC < 70%. Exclusion Criteria: - respiratory exacerbation within the 2 months preceding the study, history of asthma, significant O2 desaturation (SaO2 < 85%) at rest or during exercise, presence of another pathology that could influence exercise tolerance. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche de l'IUCPQ | Quebec |
Lead Sponsor | Collaborator |
---|---|
Laval University | Boehringer Ingelheim |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endurance time during an endurance shuttle walk | acute response (2.5 hours) following the administration of the active and comparison drug | No | |
Secondary | Compare the long-term bronchodilator-induced changes in exercise tolerance during the endurance shuttle walk | three weeks | No | |
Secondary | Evaluate the impact of long-term bronchodilation on activity of daily living evaluated using the London Chest Activity Daily Living scale | three weeks | No | |
Secondary | Cardio-respiratory responses during an endurance shutlle walk | acute response following the administration of the study medication | No |
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