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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379730
Recruitment Status : Completed
First Posted : September 22, 2006
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Prednisolone Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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 Start Date : March 21, 2006
Actual Study Completion Date : May 3, 2007

Primary Outcome Measures :
  1. 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 :
  1. Traditional lung function tests & Symptom Questionnaires

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379730

GSK Investigational Site
Mendoza, Argentina, M5500CCG
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
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00379730     History of Changes
Other Study ID Numbers: RES106087
First Posted: September 22, 2006    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by GlaxoSmithKline:
CT scan
breathing tests
lung function tests
clinical outcomes

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents