CIS001 Extension Study of Cyclosporine Inhalation Solution

Lung Transplant Clinical Trial

— CIS002  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00938236
• Other study ID #: CIS002
• Status: Terminated
• Phase: Phase 3
• First received: July 9, 2009
• Last updated: September 13, 2012
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: APT Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lung Transplant

Intervention

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

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
United States	University of Maryland	Baltimore	Maryland
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Colorado Health Sciences Cente	Denver	Colorado
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Florida Health Sciences Center	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana Methodist Research Institute	Indianapolis	Indiana
United States	UCLA School of Medicine	Los Angeles	California
United States	Loyola University Hospital	Maywood	Illinois
United States	University of Minnesota	Minneapolis	Minnesota
United States	New York Presbyterian Hospital, Columbia University Med. Ctr.	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of California, San Francisco	San Francisco	California
United States	Stanford University Medical Center	Stanford	California
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
APT Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (7)

Burkart GJ, Smaldone GC, Eldon MA, Venkataramanan R, Dauber J, Zeevi A, McCurry K, McKaveney TP, Corcoran TE, Griffith BP, Iacono AT. Lung deposition and pharmacokinetics of cyclosporine after aerosolization in lung transplant patients. Pharm Res. 2003 Feb;20(2):252-6. — View Citation

Iacono A, Dauber J, Keenan R, Spichty K, Cai J, Grgurich W, Burckart G, Smaldone G, Pham S, Ohori NP, Yousem S, Williams P, Griffith B, Zeevi A. Interleukin 6 and interferon-gamma gene expression in lung transplant recipients with refractory acute cellular rejection: implications for monitoring and inhibition by treatment with aerosolized cyclosporine. Transplantation. 1997 Jul 27;64(2):263-9. — View Citation

Iacono AT, Corcoran TE, Griffith BP, Grgurich WF, Smith DA, Zeevi A, Smaldone GC, McCurry KR, Johnson BA, Dauber JH. Aerosol cyclosporin therapy in lung transplant recipients with bronchiolitis obliterans. Eur Respir J. 2004 Mar;23(3):384-90. — View Citation

Iacono AT, Johnson BA, Grgurich WF, Youssef JG, Corcoran TE, Seiler DA, Dauber JH, Smaldone GC, Zeevi A, Yousem SA, Fung JJ, Burckart GJ, McCurry KR, Griffith BP. A randomized trial of inhaled cyclosporine in lung-transplant recipients. N Engl J Med. 2006 Jan 12;354(2):141-50. — View Citation

Iacono AT, Keenan RJ, Duncan SR, Smaldone GC, Dauber JH, Paradis IL, Ohori NP, Grgurich WF, Burckart GJ, Zeevi A, Delgado E, O'Riordan TG, Zendarsky MM, Yousem SA, Griffith BP. Aerosolized cyclosporine in lung recipients with refractory chronic rejection. Am J Respir Crit Care Med. 1996 Apr;153(4 Pt 1):1451-5. — View Citation

Iacono AT, Smaldone GC, Keenan RJ, Diot P, Dauber JH, Zeevi A, Burckart GJ, Griffith BP. Dose-related reversal of acute lung rejection by aerosolized cyclosporine. Am J Respir Crit Care Med. 1997 May;155(5):1690-8. — View Citation

Keenan RJ, Iacono A, Dauber JH, Zeevi A, Yousem SA, Ohori NP, Burckart GJ, Kawai A, Smaldone GC, Griffith BP. Treatment of refractory acute allograft rejection with aerosolized cyclosporine in lung transplant recipients. J Thorac Cardiovasc Surg. 1997 Feb;113(2):335-40; discussion 340-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the long-term safety of CIS administration		5 years	Yes