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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379730
• Other study ID #: RES106087
• Status: Completed
• Phase: Phase 1
• First received: September 20, 2006
• Last updated: July 6, 2017
• Start date: March 21, 2006
• Est. completion date: May 3, 2007

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 3, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Prednisolone

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Mendoza
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
New Zealand	GSK Investigational Site	Wellington
South Africa	GSK Investigational Site	Mowbray

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Chile,  New Zealand,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Traditional lung function tests & Symptom Questionnaires