Aerosol Cyclosporine in Chronic Obstructive Pulmonary Disease (COPD)
|ClinicalTrials.gov Identifier: NCT00783107|
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : December 11, 2012
This is a randomized, double-blinded, Phase I dose escalation-deescalation protocol (DEP) of cyclosporine inhalation solution in patients with Gold Stage III chronic obstructive pulmonary disease.
The purpose of the study is to evaluate the safety and effectiveness of aerosolized Cyclosporine in treating COPD.
The specific aims of the study are:
- To identify the short term (28 day) safety profile of CyIS immunotherapy in severe COPD (GOLD III) patients with particular attention to airway reactivity and infection risk.
- To identify the pharmacokinetic-pharmacodynamic relationship of CyIS using peripheral blood markers of an adaptive immune response as endpoints in subjects with severe COPD (GOLD III) treated short-term.
Subjects between 45 and 70 years of age with a confirmed diagnosis of COPD, Gold Stage III, and meet all the study requirements, will be enrolled in this study. A total of 24 subjects of either sex will be enrolled in this study. A total of 4 subject cohorts (n=6) will participate in the protocol.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Cyclosporine Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clinical Investigation of Aerosol Immunotherapy in COPD: A Phase I Placebo-Controlled Dose Escalation/Deescalation Trial of Aerosol Cyclosporine (CyIS) in Patients With Gold Stage III Chronic Obstructive Pulmonary Disease|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Cyclosporine Inhalation Solution, Once Daily
Placebo Comparator: Placebo
Subjects will be randomly assigned to Cyclosporine or placebo, in a ratio of 2:1.
- To evaluate the safety and effectiveness of aerosol cyclosporine (CyIS) an immunomodulating therapeutic in treating COPD [ Time Frame: Short term (28 day) safety profile ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783107
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Michael Donahoe, MD||University of Pittsburgh|