Oral Cyclosporine in Chronic Obstructive Pulmonary Disease
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.
Chronic Obstructive Pulmonary Disease
|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|
- To identify the safety profile of oral CsA immunotherapy in advanced stage COPD patients, with particular attention to nephrotoxicity, infection risk, and other recognized calcineurin toxicities. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- To identify the pharmacokinetic-pharmacodynamic relationships of oral CsA using sparse blood sampling measures of drug exposure and biomarkers of an adaptive immune response as endpoints in subjects with advanced stage COPD. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- To explore the effects of CsA on respiratory function, symptoms, quantitative computed tomographic indices, and markers of bone metabolism. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974142
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Michael Donahoe, MD||University of Pittsburgh|