Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

NCT01650545 | Completed Phase 1 Results DMC

• 1 other identifier: HP-00049596
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

case-control study; aerosolized liposomal cyclosporine A; bronchiolitis obliterans syndrome; Lung Transplantation; Lung function

Outcome Measures

Primary Outcomes (1)

• Number Of Participants With Chronic Rejection Who Met Primary Combined End-point

  Treatment failure defined as: BOS progression (\> 20% decline lung function), re-transplant, or death

  approximately 1 year

Secondary Outcomes (2)

• Cytokine Analysis From BAL Fluid in Lung

  baseline to approximately 1 year

• Overall Survival at 5 Years Follow-up

  5 years

Study Arms (2)

Liposomal Aerosol Cyclosporine

EXPERIMENTAL

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; Other: standard immune suppression, oral

Conventional oral immune suppression

ACTIVE COMPARATOR

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

Interventions

Liposomal aerosol cyclosporine DRUG

inhaled form of immune suppression

Also known as: cyclosporine

Liposomal Aerosol Cyclosporine

standard immune suppression, oral OTHER

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

Also known as: tacrolimus, rapamycin, sirolimus

Conventional oral immune suppression; Liposomal Aerosol Cyclosporine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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. doi: 10.1056/NEJMoa043204.

  PMID: 16407509 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome

Interventions

Cyclosporine; Tacrolimus; Sirolimus

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Organizing Pneumonia; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Aldo Tullio Iacono
• Organization: University of Maryland

aiacono@umm.edu

410 328 4351

Study Officials

• Aldo T Iacono, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: July 26, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2019
• Last Updated: June 1, 2023
• Results First Posted: October 25, 2017

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)