Back to resultsPrednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring CT scan, breathing tests, lung function tests, biomarkers, prednisolone, IOS, COPD, clinical outcomes
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
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
Traditional lung function tests & Symptom Questionnaires
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00379730
Brief Title
Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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 Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 21, 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 3, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
CT scan, breathing tests, lung function tests, biomarkers, prednisolone, IOS, COPD, clinical outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Traditional lung function tests & Symptom Questionnaires
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Mendoza
ZIP/Postal Code
M5500CCG
Country
Argentina
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7500551
Country
Chile
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7500691
Country
Chile
Facility Name
GSK Investigational Site
City
Wellington
ZIP/Postal Code
6035
Country
New Zealand
Facility Name
GSK Investigational Site
City
Mowbray
ZIP/Postal Code
7700
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
19164344
Citation
Lomas DA, Silverman EK, Edwards LD, Locantore NW, Miller BE, Horstman DH, Tal-Singer R; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints study investigators. Serum surfactant protein D is steroid sensitive and associated with exacerbations of COPD. Eur Respir J. 2009 Jul;34(1):95-102. doi: 10.1183/09031936.00156508. Epub 2009 Jan 22.
Results Reference
derived
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Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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