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Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01650545
First Posted: July 26, 2012
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aldo Iacono, University of Maryland
  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
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

Resource links provided by NLM:


Further study details as provided by Aldo Iacono, University of Maryland:

Primary Outcome Measures:
  • The Number of Lung Allograft Recipients Randomized With Bronchiolitis Obliterans Whom Had Progression of Disease in the L-CsA Arm Versus the Standard of Care Arm Receiving Conventional Immune Suppression Exclusively. [ Time Frame: 1 year post randomization ]
    Bronchiolitis obliterans syndrome (BOS) progression of disease defined by >= 20% decline in FEV1 from randomization or re-transplant of the lung allograft or death

  • Number Of Participants With Chronic Rejection Who Expired [ Time Frame: up to 5 years ]

Secondary Outcome Measures:
  • 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


Enrollment: 21
Actual Study Start Date: July 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other: standard immune suppression, oral
conventional drug
Other Names:
  • tacrolimus
  • rapamycin
  • sirolimus

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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  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: HP-00049596
First Submitted: June 27, 2012
First Posted: July 26, 2012
Results First Submitted: October 24, 2017
Results First Posted: October 25, 2017
Last Update Posted: October 25, 2017
Last Verified: October 2017
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
Tacrolimus
Cyclosporins
Cyclosporine
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents