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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: |
NCT03045198 |
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Date of registration:
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02/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Azithromycin on Fatty Acids in CF
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Scientific title:
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Effect of Azithromycin on Lipoproteins and Docosahexaenoic Acid in Patients With Cystic Fibrosis |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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20 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03045198 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Contacts
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Name:
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Sabina Schmitt-Grohé, 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 Children's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Delta 508 homozygous and regularly visiting the CF outpatient clinic Bonn
Exclusion Criteria:
- clinical or laboratory signs (CRP > 20 mg/L) of an exacerbation,
- treatment with systemic steroids 14 days preceeding this trial
- elevated liver function tests (> twice normal range)
Age minimum:
10 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Azithromycin
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Primary Outcome(s)
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Lipoproteins in Serum (after overnight fast)
[Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)]
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Fatty acids in EDTA-Plasma and erythrocyte membranes (after overnight fast)
[Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)]
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Secondary Outcome(s)
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ICAM1 (Serum)
[Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)]
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WBC + CRP, IgE, RAST Aspergillus fum, ECP (Serum), Carotin, Vitamin E
[Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)]
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Nutrition protocol
[Time Frame: For 7 days before day 0 and day 28]
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Matrixmetalloprotease 9 (Serum)
[Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)]
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Body weight, length
[Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)]
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Cytokines in induced sputum and whole blood
[Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)]
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Lung function test
[Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)]
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Resolvins in EDTA plasma
[Time Frame: Day 0 (before azithromycin), Day 28 (day 28 of azithromycin treatment)]
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Shwachman-Score
[Time Frame: Day 0]
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Secondary ID(s)
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Sylvia 253/12
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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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