Clinical trial NCT01329172: Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients
Official title: Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis
Dietary Modification
Keywords: PUFA
Cystic Fibrosis
Nasal brushing
Mucins
Mucin production
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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 )

Primary outcomes:
measure: Expression of Mucin "MUC5B" by measurement of messenger Ribo Nucleic Acid (mRNA) level in native airway epithelial cells obtained by nasal brushing
timeFrame: baseline and 2 months
Secondary outcomes:
measure: 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
timeFrame: baseline and two months
Other outcomes:
Locations:
city: Dunkerque
country: France
facility: Dunkerque Hospital
city: Lens
country: France
facility: Lens Hospital
city: Lille
country: France
facility: Clinical Investigation center
Study officials:
affiliation: CHRU de Lille et Université Lille 2
name: Frédéric GOTTRAND, MD, PhD
role: STUDY_CHAIR
References: