Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients

Conditions
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Cystic Fibrosis, Dietary Modification

Intervention / Treatment
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* Other: polyunsaturated fatty acids n-3
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: polyunsaturated fatty acids n-3<br>polyunsaturated fatty acids n-3 (PUFA n-3) | Other: polyunsaturated fatty acids n-3<br>* polyunsaturated fatty acids n-3 1 gram per day during two months<br>* Other names: PUFA n-3;|
| Placebo Comparator: placebo<br>sun flower oil | Other: placebo<br>* sun flower oil with Poly Unsaturated Fatty Acid 1g/day<br>* Other names: PUFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PUFA, Cystic Fibrosis, Nasal brushing, Mucins, Mucin production