Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
Aldo Iacono, University of Maryland
ClinicalTrials.gov Identifier:
NCT01650545
First received: June 27, 2012
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Disorder Related to Lung Transplantation
Bronchiolitis Obliterans
Decreased Immunologic Activity
Chronic Rejection of Lung Transplant
Drug: liposomal aerosol cyclosporine
Other: standard immune suppression, oral
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Lung Function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Preservation of lung function is an indication of overall health of the lung allograft


Secondary Outcome Measures:
  • Cytokine analysis from BAL fluid in lung [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    This is a surrogate marker of lung inflammation that may be used in addition to biopsy data


Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: liposomal aerosol cyclosporine
aerosol liposomal cyclosporine inhalational therapy for 6 months at two doses to be defined by transplant type
Drug: liposomal aerosol cyclosporine
inhaled form of immune suppression
Active Comparator: conventional immune suppression
standard immune suppression oral for lung transplant recipients tacrolimus, mycophenolate mofetil and prednisone
Other: standard immune suppression, oral
conventional drug

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650545

Contacts
Contact: Aldo T Iacono, MD 410-328-2864 aiacono@medicine.umaryland.edu

Locations
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Jennifer Davis, BS, RRT    410-328-1473    jdavis2@medicine.umaryland.edu   
Contact: Aldo T Iacono, MD    4103282864    aiacono@medicine.umaryland.edu   
Principal Investigator: Aldo T Iacono, MD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Aldo T Iacono, MD University of Maryland
  More Information

Publications:
Responsible Party: Aldo Iacono, Professor of Medicine Medical Director of Lung Transplantation, University of Maryland
ClinicalTrials.gov Identifier: NCT01650545     History of Changes
Other Study ID Numbers: AI001
Study First Received: June 27, 2012
Last Updated: July 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
case-control study
aerosolized liposomal cyclosporine A
bronchiolitis obliterans syndrome
Lung Transplantation
Lung function

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 10, 2014