Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients
NCT ID: NCT01329172
Last Updated: 2017-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2010-09-20
2017-10-31
Brief Summary
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Cystic fibrosis (CF) patients are prone to recurrent pulmonary infection have different secreted mucin pattern from healthy subjects. Long chain polyunsaturated fatty acids have been shown to influence survival and MUC5B expression in mice model of chronic pulmonary infection.
Method :
To study the impact of LCPUFA n-3 on MUC5B expression (mRNA level by RT-PCR) collected in airway epithelial cells obtained by nasal brushing. The secondary aim is to assess : MUC1, MUC2, MUC4, MUC5AC, MUC7 expression (mRNA level) in airway epithelial cells obtained by nasal brushing; Lund-Kennedy score; TNK-alpha, IL-6, IL-8 in blood plasma. This study is a double parallel, controlled double blind, randomized clinical trial : LCPUFA n-3 (1 g/day) vs placebo for 6 weeks. 30 subjects will be included in this study. Primary and secondary study end point will be assessed two times: before randomization and after 60 days of treatment.
Statistical analysis :
Treatment group and placebo will be compared using U-Mann-Whitney, intention to treat and per protocol.
Detailed Description
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Secondary Outcome Measures : Mucin MUC1, MUC2, MUC4, MUC5AC, MUC7 (mRNA level) in native airway epithelial cells obtained by nasal brushing.
Lund-Kennedy score TNF-alpha, IL-6, IL-8 in plasma
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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polyunsaturated fatty acids n-3
polyunsaturated fatty acids n-3 (PUFA n-3)
polyunsaturated fatty acids n-3
polyunsaturated fatty acids n-3 1 gram per day during two months
placebo
sun flower oil
placebo
sun flower oil with Poly Unsaturated Fatty Acid 1g/day
Interventions
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polyunsaturated fatty acids n-3
polyunsaturated fatty acids n-3 1 gram per day during two months
placebo
sun flower oil with Poly Unsaturated Fatty Acid 1g/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 30 year
* No modification of long term therapy (Corticoids, antibiotics, pancreatic extract, antiacid) before 4 weeks before randomization
Exclusion Criteria
* Patients on anticoagulants
* Contraindication to supplementation with polyunsaturated fatty acids
* Taking antibiotics in progress ( less than 15 days)
* Taking anti- inflammatory ongoing (more than one week per month , steroids , or nonsteroidal )
18 Years
30 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Frédéric GOTTRAND, MD, PhD
Role: STUDY_CHAIR
CHRU de Lille et Université Lille 2
Locations
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Dunkerque Hospital
Dunkirk, , France
Lens Hospital
Lens, , France
Clinical Investigation center
Lille, , France
Countries
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Other Identifiers
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2009-014869-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2008_47/0928
Identifier Type: -
Identifier Source: org_study_id