Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

NCT ID: NCT01650545

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2019-11-30

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.

Conditions

Disorder Related to Lung Transplantation; Bronchiolitis Obliterans; Decreased Immunologic Activity; Chronic Rejection of Lung Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposomal Aerosol Cyclosporine

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 )

Group Type: EXPERIMENTAL

Liposomal aerosol cyclosporine

Intervention Type: DRUG

inhaled form of immune suppression

standard immune suppression, oral

Intervention Type: OTHER

conventional drug

Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin

Conventional oral immune suppression

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.

Group Type: ACTIVE_COMPARATOR

standard immune suppression, oral

Intervention Type: OTHER

conventional drug

Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin

Interventions

Liposomal aerosol cyclosporine

inhaled form of immune suppression

Intervention Type: DRUG

standard immune suppression, oral

conventional drug

Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin

Intervention Type: OTHER

Other Intervention Names

cyclosporine; tacrolimus; rapamycin; sirolimus

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aldo T Iacono, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16407509 (View on PubMed)

Other Identifiers

HP-00049596

Identifier Type: -

Identifier Source: org_study_id