Observational Non-interventional Study With Spiriva in Chronic Obstructive Pulmonary Disease Patients With Exercise-induced Dyspnoea
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT00540163
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients with exercise-induced dyspnoea on treatment with Spiriva (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.
- Detailed Description
Study Design:
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1296
Inclusion Criteria
Men or women with COPD and a thoracic gas volume (TGV) of < 140% at rest, MRC value of 2 or more.
Exclusion Criteria
- Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies.
- Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram 6 weeks
- Secondary Outcome Measures
Name Time Method The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram 6 weeks
Trial Locations
- Locations (1)
Boehringer Ingelheim Investigational Site
🇩🇪Zossen, Germany