Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive; Chronic Obstructive Pulmonary Disease (COPD)
Intervention: Prednisolone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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).
Clinical Details
Official title: A Randomized, Double-blind Study of Treatment With a Known Anti-inflammatory (Prednisolone) to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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: Traditional lung function tests & Symptom Questionnaires
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Investigational Site, Mendoza M5500CCG, Argentina
GSK Investigational Site, Wellington 6035, New Zealand
GSK Investigational Site, Mowbray 7700, South Africa
GSK Investigational Site, Santiago, Región Metro De Santiago 7500551, Chile
GSK Investigational Site, Santiago, Región Metro De Santiago 7500691, Chile
Additional Information
Starting date: March 2006
Last updated: May 31, 2012
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