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Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

Primary Purpose

Disorder Related to Lung Transplantation, Bronchiolitis Obliterans, Decreased Immunologic Activity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Liposomal aerosol cyclosporine
standard immune suppression, oral
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder Related to Lung Transplantation focused on measuring case-control study, aerosolized liposomal cyclosporine A, bronchiolitis obliterans syndrome, Lung Transplantation, Lung function

Eligibility Criteria

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

Inclusion Criteria:

Chronic rejection

  1. Bronchiolitis obliterans diagnosed by bronchiolitis obliterans syndrome and > 20% decline from the individual patient's best FEV1 is observed
  2. Recipient of a double or single lung transplant
  3. Receiving immunosuppressive treatment according to institutional standards

Exclusion criteria:

  1. Active invasive bacterial, viral or fungal infection
  2. Current mechanical ventilation
  3. Pregnant or breast-feeding woman
  4. Known hypersensitivity to cyclosporine A
  5. Serum creatinine value of more than 265 μmol/L (3 mg/dL) or chronic dialysis
  6. Receipt of an investigational drug as part of a clinical trial

Sites / Locations

  • University of Maryland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal Aerosol Cyclosporine

Conventional oral immune suppression

Arm Description

Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )

Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone. Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone rapamycin described in the subsequent section as well.

Outcomes

Primary Outcome Measures

Number Of Participants With Chronic Rejection Who Met Primary Combined End-point
Treatment failure defined as: BOS progression (> 20% decline lung function), re-transplant, or death

Secondary Outcome Measures

Cytokine Analysis From BAL Fluid in Lung
Multiple cytokines were assessed as markers of lung inflammation that may be used in addition to biopsy data, collected per patient as clinically indicated during the follow-up interval. Values are reported as mean change from baseline in each group, per week
Overall Survival at 5 Years Follow-up
Number of participants surviving at 5 year follow-up

Full Information

First Posted
June 27, 2012
Last Updated
May 4, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT01650545
Brief Title
Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients
Official Title
A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A in the treatment of chronic rejection in lung transplant recipients with bronchiolitis obliterans syndrome (BOS). The primary objective is to evaluate the efficacy of liposomal cyclosporine A in the treatment of chronic rejection. Pulmonary function and changes in BOS grade are the primary end points.
Detailed Description
This is a randomized single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) in the treatment of chronic rejection in lung transplant recipients with Grade 1 or 2 BOS. The primary endpoints will include: Improvement or stabilization of pulmonary function test (FEV1) from baseline Stabilization of histology (no deterioration from baseline) Safety of the preparation The secondary endpoints will include: Pharmacokinetics and distribution of CsA in blood - Change in cytokine levels from BAL specimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder Related to Lung Transplantation, Bronchiolitis Obliterans, Decreased Immunologic Activity, Chronic Rejection of Lung Transplant
Keywords
case-control study, aerosolized liposomal cyclosporine A, bronchiolitis obliterans syndrome, Lung Transplantation, Lung function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Aerosol Cyclosporine
Arm Type
Experimental
Arm Description
Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )
Arm Title
Conventional oral immune suppression
Arm Type
Active Comparator
Arm Description
Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone. Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone rapamycin described in the subsequent section as well.
Intervention Type
Drug
Intervention Name(s)
Liposomal aerosol cyclosporine
Other Intervention Name(s)
cyclosporine
Intervention Description
inhaled form of immune suppression
Intervention Type
Other
Intervention Name(s)
standard immune suppression, oral
Other Intervention Name(s)
tacrolimus, rapamycin, sirolimus
Intervention Description
conventional drug Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin
Primary Outcome Measure Information:
Title
Number Of Participants With Chronic Rejection Who Met Primary Combined End-point
Description
Treatment failure defined as: BOS progression (> 20% decline lung function), re-transplant, or death
Time Frame
approximately 1 year
Secondary Outcome Measure Information:
Title
Cytokine Analysis From BAL Fluid in Lung
Description
Multiple cytokines were assessed as markers of lung inflammation that may be used in addition to biopsy data, collected per patient as clinically indicated during the follow-up interval. Values are reported as mean change from baseline in each group, per week
Time Frame
baseline to approximately 1 year
Title
Overall Survival at 5 Years Follow-up
Description
Number of participants surviving at 5 year follow-up
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic rejection Bronchiolitis obliterans diagnosed by bronchiolitis obliterans syndrome and > 20% decline from the individual patient's best FEV1 is observed Recipient of a double or single lung transplant Receiving immunosuppressive treatment according to institutional standards Exclusion criteria: Active invasive bacterial, viral or fungal infection Current mechanical ventilation Pregnant or breast-feeding woman Known hypersensitivity to cyclosporine A Serum creatinine value of more than 265 μmol/L (3 mg/dL) or chronic dialysis Receipt of an investigational drug as part of a clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo T Iacono, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
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Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

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