CIS001 Extension Study of Cyclosporine Inhalation Solution

Phase 3

Terminated

• Conditions: Lung Transplant
• Interventions: Drug: Cyclosporine Inhalation Solution (CIS)

• Registration Number: NCT00938236
• Lead Sponsor: APT Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Study Start: 2009-12
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Enrollment in study CIS001
2. Written informed consent for CIS002
3. Use of an effective means of contraception by women of childbearing potential

Exclusion Criteria

1. Any unresolved or irreversible CIS-related ongoing serious adverse event
2. Subjects who have developed newly emergent conditions, injuries, diagnoses, physical examination findings, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk of treatment complications
3. Subjects with suspected or documented allergy to propylene glycol and/or cyclosporine
4. Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant
5. Women who are breastfeeding
6. Subjects unable to comply with all protocol requirements and follow-up procedures
7. Subjects who discontinued from CIS002 to participate in another clinical trial and have received any investigational treatment (other than CIS) within 14 days of titration visit 1/baseline.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inhaled cyclosporine	Cyclosporine Inhalation Solution (CIS)	Extended access to inhaled cyclosporine for patients from treatment and control arms of Phase 3 study CIS001

Primary Outcome Measures

Name	Time	Method
To assess the long-term safety of CIS administration	5 years

Trial Locations

Locations (16)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

UCLA School of Medicine; 🇺🇸 Los Angeles, California, United States

New York Presbyterian Hospital, Columbia University Med. Ctr.; 🇺🇸 New York, New York, United States

University of Florida Health Sciences Center; 🇺🇸 Gainesville, Florida, United States

Loyola University Hospital; 🇺🇸 Maywood, Illinois, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Toronto; 🇨🇦 Toronto, Ontario, Canada

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Indiana Methodist Research Institute; 🇺🇸 Indianapolis, Indiana, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado Health Sciences Cente; 🇺🇸 Denver, Colorado, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States