Clinical Research Details
Title:
An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001. Submission of protocol dated 7/9/09, clarification memo dated 7/15/09, diary cards, script for the DVD for patient teaching, appointment cards reminders, instructions for removing and replacing the hose-barb connector on the invacare mobilarie compressor, and advertising brochure.
Purpose:
To provide access to CIS treatment to subjects previously enrolled in the APT study CIS001 or to subjects screened for CIS001 but not enrolled due to an SAE persisting beyond post-transplant day 70;To assess the long-term safety of CIS administration;To collect data on extended follow up and survival in lung transplant patients treated with CIS;To assess the long-term safety of CIS administration via the recording of serious adverse events and local respiratory adverse events associated with study drug administration during the titration phase.
Study Number:
202054081909
Number of Patients:
200