Cystic Fibrosis Clinical Trial
Official title:
Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients
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.
Primary Outcome Measure : Mucin MUC5B (mRNA level) in native airway epithelial cells obtained
by nasal brushing
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
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