Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Phase 1
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00379730
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Prednisolone will be used as a model medication to identify new clinical outcomes for future evaluation of new therapies in short-term studies (up to 4 weeks) in patients with Chronic Obstructive Pulmonary Disease (COPD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- An established clinical history of COPD
- Evidence of bronchitis
- Current or ex-smoker
Exclusion Criteria
- COPD exacerbation requiring steroid and/or antibiotics in the last month
- Taking oral or inhaled steroids for more than 14 days in the last 6 months
- Unable to withhold salbutamol/albuterol for a 6 hour period
- History of alcohol, substance or drug abuse within the last year.
- Other significant medical condition e.g. diabetes
- Cancer that has not been in complete remission for at least 5 years
- As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method lung function tests using a system called Impulse oscillometry (IOS). CT scans to measure the thickness of the tubes in the lungs Blood, sputum and breath samples to measure chemical products in the lungs and body that relate to COPD
- Secondary Outcome Measures
Name Time Method Traditional lung function tests & Symptom Questionnaires
Trial Locations
- Locations (1)
GSK Investigational Site
πΏπ¦Mowbray, South Africa