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Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Primary Purpose

Lung Transplant

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Cyclosporine Inhalation Solution
Sponsored by
APT Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Lung Transplant focused on measuring lung, transplant, transplant rejection, Cyclosporine, bronchiolitis obliterans, aerosol

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Single-or double-lung transplant recipients who have a high risk for developing chronic rejection
  • Single or double-lung transplant recipients who have developed chronic rejection
  • Single or double-lung transplant recipients who have serious or life-threatening complications of systemic immunosuppressive therapy

Exclusion Criteria:

  • Known hypersensitivity to cyclosporine or propylene glycol (PG)
  • Females who are pregnant or are considering becoming pregnant
  • Females who are breast feeding a child.

Sites / Locations

  • University of California at San Francisco
  • University of Florida Health Sciences Center
  • Tampa General Hospital
  • University of Maryland Medical Center
  • Children's Hospital Boston
  • Cleveland Clinic
  • University of Pittsburgh Medical Center
  • Baylor Clinic, Baylor College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 5, 2008
Last Updated
September 13, 2012
Sponsor
APT Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00633373
Brief Title
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
Official Title
An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
Study Type
Expanded Access

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplant
Keywords
lung, transplant, transplant rejection, Cyclosporine, bronchiolitis obliterans, aerosol

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cyclosporine Inhalation Solution
Intervention Description
Cyclosporine USP Inhalation Solution (CIS) 300mg/4.8 mL delivered via a disposable nebulizer. A titration phase of 10 days is recommended starting with 100 mg and then increasing over the 10 days to a maximum of 300 mg or the highest tolerated dose.

10. Eligibility

Sex
All
Eligibility Criteria
Inclusion Criteria: Single-or double-lung transplant recipients who have a high risk for developing chronic rejection Single or double-lung transplant recipients who have developed chronic rejection Single or double-lung transplant recipients who have serious or life-threatening complications of systemic immunosuppressive therapy Exclusion Criteria: Known hypersensitivity to cyclosporine or propylene glycol (PG) Females who are pregnant or are considering becoming pregnant Females who are breast feeding a child.
Facility Information:
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
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
33606
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
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 Clinic, Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

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
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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
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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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Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

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