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

This study has been completed.

First Received: September 20, 2006 Last Updated: December 10, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00379730

Purpose

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).

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Prednisolone	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacodynamics Study
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)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) CT Scans

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment:	90
Study Start Date:	March 2006

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379730

Locations

Argentina
GSK Investigational Site
Mendoza, Argentina, M5500CCG
Chile, Región Metro De Santiago
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500551
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500691
New Zealand
GSK Investigational Site
Wellington, New Zealand, 6035
South Africa
GSK Investigational Site
Mowbray, South Africa, 7700

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, MSc, FPPM

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	RES106087
Study First Received:	September 20, 2006
Last Updated:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00379730 History of Changes
Health Authority:	South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:

COPD
biomarkers
prednisolone
clinical outcomes

lung function tests
breathing tests
CT scan
IOS

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Methylprednisolone Hemisuccinate

Antineoplastic Agents, Hormonal
Respiration Disorders
Gastrointestinal Agents
Methylprednisolone acetate
Protective Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Prednisolone
Peripheral Nervous System Agents
Central Nervous System Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010