CIS001 Extension Study of Cyclosporine Inhalation Solution

NCT00938236 | Terminated Phase 3 DMC

• 1 other identifier: CIS002
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 16

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.

Conditions

Lung Transplant

Keywords

lung transplant; lung transplant recipient; bronchiolitis obliterans syndrome; bronchiolitis obliterans; single lung transplant; double lung transplant; heart-lung transplant; Aerosol

Outcome Measures

Primary Outcomes (1)

• To assess the long-term safety of CIS administration

  5 years

Study Arms (1)

Inhaled cyclosporine

OTHER

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

Drug: Cyclosporine Inhalation Solution (CIS)

Interventions

Cyclosporine Inhalation Solution (CIS) DRUG

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

Inhaled cyclosporine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• APT Pharmaceuticals, Inc.: lead

Study Sites (16)

UCLA School of Medicine

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Colorado Health Sciences Cente

Denver, Colorado, 80262, United States

Location

University of Florida Health Sciences Center

Gainesville, Florida, 32610, United States

Location

Tampa General Hospital

Tampa, Florida, 33601, United States

Location

Loyola University Hospital

Maywood, Illinois, 60153, United States

Location

Indiana Methodist Research Institute

Indianapolis, Indiana, 46202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

New York Presbyterian Hospital, Columbia University Med. Ctr.

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22402, United States

Location

University of Toronto

Toronto, Ontario, M5G 2N2, Canada

Location

Related 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. doi: 10.1023/a:1022275222207.

  PMID: 12636164 BACKGROUND

• 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. doi: 10.1164/ajrccm.155.5.9154878.

  PMID: 9154878 BACKGROUND

• 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. doi: 10.1016/S0022-5223(97)70331-3.

  PMID: 9040628 BACKGROUND

• 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. doi: 10.1097/00007890-199707270-00015.

  PMID: 9256185 BACKGROUND

• 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. doi: 10.1056/NEJMoa043204.

  PMID: 16407509 BACKGROUND

• 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. doi: 10.1183/09031936.04.00058504.

  PMID: 15065826 BACKGROUND

• 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. doi: 10.1164/ajrccm.153.4.8616581.

  PMID: 8616581 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Bruce A Johnson, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Jeffrey Golden, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 13, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

CA (1); US (15)