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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01650545 |
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Date of registration:
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27/06/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients
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Scientific title:
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A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01650545 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Aldo T Iacono, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Maryland, College Park |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Rejection of Lung Transplant
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Decreased Immunologic Activity
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Bronchiolitis Obliterans
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Disorder Related to Lung Transplantation
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Intervention(s)
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Other: standard immune suppression, oral
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Drug: Liposomal aerosol cyclosporine
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Primary Outcome(s)
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Number Of Participants With Chronic Rejection Who Met Primary Combined End-point
[Time Frame: approximately 1 year]
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Secondary Outcome(s)
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Overall Survival at 5 Years Follow-up
[Time Frame: 5 years]
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Cytokine Analysis From BAL Fluid in Lung
[Time Frame: baseline to approximately 1 year]
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Secondary ID(s)
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HP-00049596
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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