Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

Bronchiolitis Obliterans Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650545
• Other study ID #: HP-00049596
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2012
• Est. completion date: November 2019

Study information

• Verified date: March 2018
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2019
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Liposomal aerosol cyclosporine
inhaled form of immune suppression

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

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cytokine Analysis From BAL Fluid in Lung	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	baseline to approximately 1 year
Secondary	Overall Survival at 5 Years Follow-up	Number of participants surviving at 5 year follow-up	5 years