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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01650545
Other study ID # HP-00049596
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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