Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
CT scan, breathing tests, lung function tests, biomarkers, prednisolone, IOS, COPD, clinical outcomes
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).
Interventions
DRUGPrednisolone
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Traditional lung function tests & Symptom Questionnaires | — |
Countries
Argentina, Chile, New Zealand, South Africa
Outcome results
None listed