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

Tracking Information

First Received Date ^ICMJE

September 20, 2006

Last Updated Date

December 10, 2009

Start Date ^ICMJE

March 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Blood, sputum and breath samples to measure chemical products in the lungs and body that relate to COPD
Lung function tests using a system called Impulse oscillometry (IOS).
CT scans to measure the thickness of the tubes in the lungs

Change History

Complete list of historical versions of study NCT00379730 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Traditional lung function tests & Symptom Questionnaires

Original Secondary Outcome Measures ^ICMJE

Traditional lung function tests
Symptom Questionnaires

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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).

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

Drug: Prednisolone

Other Name: Prednisolone

Study Arms / Comparison Groups

Publications *

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. Epub 2009 Jan 22.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, Chile, New Zealand, South Africa

Administrative Information

NCT ID ^ICMJE

NCT00379730

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

RES106087

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD, MSc, FPPM

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP