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Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

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ClinicalTrials.gov Identifier: NCT01650545
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : October 25, 2017
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Aldo Iacono, University of Maryland

June 27, 2012
July 26, 2012
October 24, 2017
October 25, 2017
March 2, 2018
July 2012
August 2015   (Final data collection date for primary outcome measure)
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
Lung Function [ Time Frame: 2 years ]
Preservation of lung function is an indication of overall health of the lung allograft
Complete list of historical versions of study NCT01650545 on ClinicalTrials.gov Archive Site
  • 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
  • Overall Survival at 5 Years Follow-up [ Time Frame: 5 years ]
    Number of participants surviving at 5 year follow-up
Cytokine Analysis From BAL Fluid in Lung [ Time Frame: 2 years ]
This is a surrogate marker of lung inflammation that may be used in addition to biopsy data
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
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 Name: cyclosporine
  • Other: standard immune suppression, oral

    conventional drug

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

    Other Names:
    • tacrolimus
    • rapamycin
    • sirolimus
  • Experimental: 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 )
    Interventions:
    • Drug: Liposomal aerosol cyclosporine
    • Other: standard immune suppression, oral
  • Active Comparator: 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.

    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.
 
Completed
21
30
August 2015
August 2015   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01650545
HP-00049596
Yes
Not Provided
Plan to Share IPD: No
Aldo Iacono, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Aldo T Iacono, MD University of Maryland
University of Maryland
March 2018

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