Cystic Fibrosis Clinical Trial
— NOSTRILOfficial title:
Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients
Verified date | December 2017 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background :
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria : - Cystic fibrosis patient - Aged 18 to 30 year - No modification of long term therapy (Corticoids, antibiotics, pancreatic extract, antiacid) before 4 weeks before randomization Exclusion Criteria: - Awaiting transplantation - 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 ) |
Country | Name | City | State |
---|---|---|---|
France | Dunkerque Hospital | Dunkerque | |
France | Lens Hospital | Lens | |
France | Clinical Investigation center | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Expression of Mucin "MUC5B" by measurement of messenger Ribo Nucleic Acid (mRNA) level in native airway epithelial cells obtained by nasal brushing | baseline and 2 months | ||
Secondary | 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 | baseline and two months |
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