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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

Brief 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.


Condition or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: 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
Actual Study Start Date : July 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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 )
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
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.

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650545


Locations
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Aldo T Iacono, MD University of Maryland

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: HP-00049596
First Posted: July 26, 2012    Key Record Dates
Results First Posted: October 25, 2017
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Bronchiolitis Obliterans
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Prednisone
Mycophenolic Acid
Sirolimus
Everolimus
Tacrolimus
Cyclosporins
Cyclosporine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents