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CIS001 Extension Study of Cyclosporine Inhalation Solution (CIS002)

Primary Purpose

Lung Transplant

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cyclosporine Inhalation Solution (CIS)
Sponsored by
APT Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Transplant focused on measuring lung transplant, lung transplant recipient, bronchiolitis obliterans syndrome, bronchiolitis obliterans, single lung transplant, double lung transplant, heart-lung transplant, Aerosol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA School of Medicine
  • University of California, San Francisco
  • Stanford University Medical Center
  • University of Colorado Health Sciences Cente
  • University of Florida Health Sciences Center
  • Tampa General Hospital
  • Loyola University Hospital
  • Indiana Methodist Research Institute
  • University of Maryland
  • University of Minnesota
  • New York Presbyterian Hospital, Columbia University Med. Ctr.
  • Cleveland Clinic
  • University of Pittsburgh Medical Center
  • Baylor College of Medicine
  • Inova Fairfax Hospital
  • University of Toronto

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Inhaled cyclosporine

Arm Description

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

Outcomes

Primary Outcome Measures

To assess the long-term safety of CIS administration

Secondary Outcome Measures

Full Information

First Posted
July 9, 2009
Last Updated
September 13, 2012
Sponsor
APT Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00938236
Brief Title
CIS001 Extension Study of Cyclosporine Inhalation Solution
Acronym
CIS002
Official Title
CIS002: An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Parent study CIS001 was completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
APT Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplant
Keywords
lung transplant, lung transplant recipient, bronchiolitis obliterans syndrome, bronchiolitis obliterans, single lung transplant, double lung transplant, heart-lung transplant, Aerosol

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled cyclosporine
Arm Type
Other
Arm Description
Extended access to inhaled cyclosporine for patients from treatment and control arms of Phase 3 study CIS001
Intervention Type
Drug
Intervention Name(s)
Cyclosporine Inhalation Solution (CIS)
Intervention Description
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
Primary Outcome Measure Information:
Title
To assess the long-term safety of CIS administration
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce A Johnson, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Golden, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Health Sciences Cente
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
University of Florida Health Sciences Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33601
Country
United States
Facility Name
Loyola University Hospital
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana Methodist Research Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
New York Presbyterian Hospital, Columbia University Med. Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22402
Country
United States
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12636164
Citation
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.
Results Reference
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PubMed Identifier
9154878
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. doi: 10.1164/ajrccm.155.5.9154878.
Results Reference
background
PubMed Identifier
9040628
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. doi: 10.1016/S0022-5223(97)70331-3.
Results Reference
background
PubMed Identifier
9256185
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. doi: 10.1097/00007890-199707270-00015.
Results Reference
background
PubMed Identifier
16407509
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. doi: 10.1056/NEJMoa043204.
Results Reference
background
PubMed Identifier
15065826
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. doi: 10.1183/09031936.04.00058504.
Results Reference
background
PubMed Identifier
8616581
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. doi: 10.1164/ajrccm.153.4.8616581.
Results Reference
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CIS001 Extension Study of Cyclosporine Inhalation Solution

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