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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00379730 |
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) |
Estimated Enrollment: | 90 |
Study Start Date: | March 2006 |
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 6004, New Zealand, 6004 | |
South Africa | |
GSK Investigational Site | |
Mowbray, South Africa, 7700 |
Study Director: | GSK Clinical Trials, MD, MSc, FPPM | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | RES106087 |
Study First Received: | September 20, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00379730 |
Health Authority: | South Africa: Medicines Control Council |
COPD biomarkers prednisolone clinical outcomes |
lung function tests breathing tests CT scan IOS |
Lung Diseases, Obstructive Respiratory Tract Diseases Methylprednisolone Lung Diseases Prednisolone |
Respiration Disorders Methylprednisolone acetate Prednisolone acetate Methylprednisolone Hemisuccinate Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Protective Agents |
Neuroprotective Agents Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |