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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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19 February 2015 |
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Main ID: |
NCT00378677 |
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Date of registration:
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20/09/2006 |
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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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Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome
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Scientific title:
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Pilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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7 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00378677 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 0
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Wim Van Der Bij, MD, PhD |
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Address:
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Telephone:
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+31 50 3616161 |
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Email:
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Affiliation:
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Name:
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Gerrit Zijlstra, Pharmacist |
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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 Groningen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed Informed Consent
- Primary lung transplant
- Tacrolimus as maintenance therapy
- Bronchiolitis Obliterans Syndrome stages 1 - 3: FEV1<80% of baseline
- At least 3 months after last usual BOS intervention
- Declining FEV1 after last usual BOS intervention
Exclusion Criteria:
- Cyclosporine as maintenance therapy
- Bronchiolitis Obliterans Syndrome 0: FEV1>80%
- Renal failure: Glomerular Filtration Rate < 30 ml/min
- Chronic airway infections
- Clinical stability
- Pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Transplantation
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Bronchiolitis Obliterans
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Intervention(s)
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Drug: Cyclosporine A dry powder inhalation (Drug)
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Primary Outcome(s)
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Systemic uptake of Cyclosporine A
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Change in Forced Expiratory Volume in 1 second before and after intervention
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Amount of lung deposition of cyclosporine A
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Secondary Outcome(s)
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Kidney function (GFR and serum creat)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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