Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2007-05-03
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.