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

Not Applicable

Terminated

• Conditions: Cystic Fibrosis; Dietary Modification

• Registration Number: NCT01329172
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2010-05-21
• Study Start: 2010-09-20
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-21
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Dunkerque Hospital; 🇫🇷 Dunkerque, France

Lens Hospital; 🇫🇷 Lens, France

Clinical Investigation center; 🇫🇷 Lille, France