NCT00938236

CIS001 Extension Study of Cyclosporine Inhalation Solution

CIS002: An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: APT Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.

Conditions

• Lung Transplant

Interventions

Type	Name	Description
DRUG	Cyclosporine Inhalation Solution (CIS)	Cyclosporine (USP) Inhalation Solution; 300mg/4.8 mL in propylene glycol (USP) at a concentration of 62.5 mg/mL; 3 times a week for study duration

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2009-07-13
• Last updated: 2012-09-17

Locations

16 sites across 2 countries: United States, Canada