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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

June 27, 2012
July 23, 2012
June 2012
February 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01650545 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients
A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Disorder Related to Lung Transplantation
  • Bronchiolitis Obliterans
  • Decreased Immunologic Activity
  • Chronic Rejection of Lung Transplant
  • Drug: liposomal aerosol cyclosporine
    inhaled form of immune suppression
  • Other: standard immune suppression, oral
    conventional drug
  • Experimental: liposomal aerosol cyclosporine
    aerosol liposomal cyclosporine inhalational therapy for 6 months at two doses to be defined by transplant type
    Intervention: Drug: liposomal aerosol cyclosporine
  • Active Comparator: conventional immune suppression
    standard immune suppression oral for lung transplant recipients tacrolimus, mycophenolate mofetil and prednisone
    Intervention: Other: standard immune suppression, oral
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
February 2015
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Aldo T Iacono, MD 410-328-2864 aiacono@medicine.umaryland.edu
United States
 
NCT01650545
AI001
Yes
Aldo Iacono, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Aldo T Iacono, MD University of Maryland
University of Maryland
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP