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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01329172

Acronym

NOSTRIL

Enrollment

Registered

2011-04-05

Start date

2010-09-20

Completion date

2017-10-31

Last updated

2017-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Dietary Modification

Keywords

PUFA, Cystic Fibrosis, Nasal brushing, Mucins, Mucin production

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

Interventions

OTHERpolyunsaturated fatty acids n-3

polyunsaturated fatty acids n-3 1 gram per day during two months

OTHERplacebo

sun flower oil with Poly Unsaturated Fatty Acid 1g/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

Healthy volunteers

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 )

Design outcomes

Primary

Measure	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

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026