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
Verified date | March 2018 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
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
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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