Chronic Obstructive Pulmonary Disease Clinical Trial
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
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:
1. 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.
2. 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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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