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NCT Number: NCT01650545

Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

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.

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Key information

Conditions

Disorder Related to Lung Transplantation Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Rejection of Lung Transplant Decreased Immunologic Activity Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal aerosol cyclosporine

Drug

inhaled form of immune suppression

Other names: cyclosporine

standard immune suppression, oral

Other

conventional drug

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

Other names: tacrolimus, rapamycin, sirolimus

Primary outcomes

  1. Number Of Participants With Chronic Rejection Who Met Primary Combined End-point

    Time frame: approximately 1 year

    Treatment failure defined as: BOS progression (> 20% decline lung function), re-transplant, or death

Secondary outcomes

  1. Cytokine Analysis From BAL Fluid in Lung

    Time frame: baseline to approximately 1 year

    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

  2. Overall Survival at 5 Years Follow-up

    Time frame: 5 years

    Number of participants surviving at 5 year follow-up

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2019
First posted
Jul 26, 2012
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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