Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

This study is currently recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 27, 2012

Last Updated Date

July 23, 2012

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01650545 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

Official Title ^ICMJE

A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Disorder Related to Lung Transplantation
Bronchiolitis Obliterans
Decreased Immunologic Activity
Chronic Rejection of Lung Transplant

Intervention ^ICMJE

Drug: liposomal aerosol cyclosporine
inhaled form of immune suppression
Other: standard immune suppression, oral
conventional drug

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2015

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chronic rejection

Bronchiolitis obliterans diagnosed by bronchiolitis obliterans syndrome and > 20% decline from the individual patient's best FEV1 is observed
Recipient of a double or single lung transplant
Receiving immunosuppressive treatment according to institutional standards

Exclusion criteria:

Active invasive bacterial, viral or fungal infection
Current mechanical ventilation
Pregnant or breast-feeding woman
Known hypersensitivity to cyclosporine A
Serum creatinine value of more than 265 μmol/L (3 mg/dL) or chronic dialysis
Receipt of an investigational drug as part of a clinical trial

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Aldo T Iacono, MD

410-328-2864

aiacono@medicine.umaryland.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01650545

Other Study ID Numbers ^ICMJE

AI001

Has Data Monitoring Committee

Yes

Responsible Party

Aldo Iacono, University of Maryland

Study Sponsor ^ICMJE

University of Maryland

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Aldo T Iacono, MD

University of Maryland

Information Provided By

University of Maryland

Verification Date

July 2012

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

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