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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00379730
First received: September 20, 2006
Last updated: May 31, 2012
Last verified: February 2011
History of Changes

September 20, 2006
May 31, 2012
March 2006
Not Provided
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
  • 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
Complete list of historical versions of study NCT00379730 on ClinicalTrials.gov Archive Site
Traditional lung function tests & Symptom Questionnaires
  • Traditional lung function tests
  • Symptom Questionnaires
Not Provided
Not Provided
 
Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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)

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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Chronic Obstructive Pulmonary Disease (COPD)
Drug: Prednisolone
Other Name: Prednisolone
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
Not Provided
Not Provided

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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   New Zealand,   South Africa
 
NCT00379730
RES106087
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

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