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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by (Responsible Party): | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00974142 |
Purpose
This is a randomized, double-blinded, placebo-controlled trial of oral Cyclosporine A (CsA) in patients with advanced stage chronic obstructive pulmonary disease. The purpose of the study is to evaluate the safety and effectiveness of CsA as a therapy for the adaptive immune response in advanced stage Chronic Obstructive Pulmonary Disease (COPD).
Subjects between 45 and 80 years of age with a confirmed diagnosis of advanced stage COPD, not responsive to conventional inhaler therapy, who meet all the study requirements, will be enrolled in this study. A total of 30 subjects of either sex will be enrolled in this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Cyclosporine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blinded, Placebo-Controlled Protocol of Oral Cyclosporine in Patients With Advanced Stage Chronic Obstructive Pulmonary Disease |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cyclosporine |
Drug: Cyclosporine
The study population (n=30) will be divided into two patient cohorts intended to receive cyclosporine at an initial dosing of 3.0 mg/kg/day or placebo, in a randomized ratio of 1:1.
Other Name: Neoral
|
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nydia Chien, MSN | 412-682-1626 | chienn@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Nydia Chien, MSN 412-682-1626 chienn@upmc.edu | |
| Principal Investigator: | Michael Donahoe, MD | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00974142 History of Changes |
| Other Study ID Numbers: | PRO09050330 |
| Study First Received: | September 9, 2009 |
| Last Updated: | September 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
COPD Chronic Obstructive Pulmonary Disease Cyclosporine Oral Immunotherapy Advanced stage |
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Cyclosporins Cyclosporine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |