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
  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
Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Prednisolone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


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
Intervention Details:
    Drug: Prednisolone
    Other Name: Prednisolone
  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
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, see Learn About Clinical Studies.

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

Locations
Argentina
GSK Investigational Site
Mendoza, Argentina, M5500CCG
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500691
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500551
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 GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00379730     History of Changes
Other Study ID Numbers: RES106087
Study First Received: September 20, 2006
Last Updated: May 31, 2012
Health Authority: South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:
CT scan
breathing tests
lung function tests
biomarkers
prednisolone
IOS
COPD
clinical outcomes

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

ClinicalTrials.gov processed this record on August 21, 2014