Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00379730
First received: September 20, 2006
Last updated: May 31, 2012
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
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 |
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
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 Respiration Disorders 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 |
ClinicalTrials.gov processed this record on May 23, 2013