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Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

NCT01650545 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-06-01

Study results available
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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.

Conditions

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

Interventions

DRUG

Liposomal aerosol cyclosporine

inhaled form of immune suppression

OTHER

standard immune suppression, oral

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

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Aldo T Iacono, MD · University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-08-31
Completion
2019-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01650545 on ClinicalTrials.gov