CIS001 Extension Study of Cyclosporine Inhalation Solution - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lung Transplant	Drug: Cyclosporine Inhalation Solution (CIS)	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	CIS002: An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001

Resource links provided by NLM:

MedlinePlus related topics: Lung Transplantation

Drug Information available for: Cyclosporine

U.S. FDA Resources

Further study details as provided by APT Pharmaceuticals, Inc.:

Primary Outcome Measures:

To assess the long-term safety of CIS administration [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment:	17
Study Start Date:	December 2009
Study Completion Date:	December 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Inhaled cyclosporine Extended access to inhaled cyclosporine for patients from treatment and control arms of Phase 3 study CIS001	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any unresolved or irreversible CIS-related ongoing serious adverse event
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
Subjects with suspected or documented allergy to propylene glycol and/or cyclosporine
Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant
Women who are breastfeeding
Subjects unable to comply with all protocol requirements and follow-up procedures
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938236

Locations

United States, California
UCLA School of Medicine
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94143
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Health Sciences Cente
Denver, Colorado, United States, 80262
United States, Florida
University of Florida Health Sciences Center
Gainesville, Florida, United States, 32610
Tampa General Hospital
Tampa, Florida, United States, 33601
United States, Illinois
Loyola University Hospital
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana Methodist Research Institute
Indianapolis, Indiana, United States, 46202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
New York Presbyterian Hospital, Columbia University Med. Ctr.
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22402
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5G 2N2

Sponsors and Collaborators

APT Pharmaceuticals, Inc.

Investigators

Principal Investigator:	Bruce A Johnson, MD	University of Pittsburgh
Principal Investigator:	Jeffrey Golden, MD	University of California, San Francisco

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

Responsible Party:	APT Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00938236 History of Changes
Other Study ID Numbers:	CIS002
Study First Received:	July 9, 2009
Last Updated:	September 13, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by APT Pharmaceuticals, Inc.:

lung transplant
lung transplant recipient
bronchiolitis obliterans syndrome
bronchiolitis obliterans

single lung transplant
double lung transplant
heart-lung transplant
Aerosol

Additional relevant MeSH terms:

Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors

Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013

CIS001 Extension Study of Cyclosporine Inhalation Solution (CIS002)