NCT00974142

Oral Cyclosporine in Chronic Obstructive Pulmonary Disease

A Randomized, Double-Blinded, Placebo-Controlled Protocol of Oral Cyclosporine in Patients With Advanced Stage Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Michael Donahoe · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Cyclosporine	Fifteen patients will receive cyclosporine at an initial dosing of 3.0 mg/kg/day.
DRUG	Placebo	Fifteen patients will receive will receive placebo.

Timeline

• Start date: 2009-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2009-09-10
• Last updated: 2025-06-25
• Results posted: 2018-05-09

Locations

1 site across 1 country: United States