Status:
COMPLETED
Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
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 Pulm...
Eligibility Criteria
Inclusion
- An established clinical history of COPD
- Evidence of bronchitis
- Current or ex-smoker
Exclusion
- 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.
Key Trial Info
Start Date :
March 21 2006
Trial Type :
INTERVENTIONAL
End Date :
May 3 2007
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00379730
Start Date
March 21 2006
End Date
May 3 2007
Last Update
July 11 2017
Active Locations (5)
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1
GSK Investigational Site
Mendoza, Argentina, M5500CCG
2
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile, 7500551
3
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile, 7500691
4
GSK Investigational Site
Wellington, New Zealand, 6035