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

Cystic Fibrosis Clinical Trial

— NOSTRIL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01329172
• Other study ID #: 2008_47/0928
• Secondary ID: 2009-014869-43
• Status: Terminated
• Phase: N/A
• First received: May 21, 2010
• Last updated: December 21, 2017
• Start date: September 20, 2010
• Est. completion date: October 2017

Study information

• Verified date: December 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Cystic Fibrosis
• Dietary Modification
• Fibrosis

Intervention

Other:
• polyunsaturated fatty acids n-3
polyunsaturated fatty acids n-3 1 gram per day during two months
• placebo
sun flower oil with Poly Unsaturated Fatty Acid 1g/day

Locations

Country	Name	City	State
France	Dunkerque Hospital	Dunkerque
France	Lens Hospital	Lens
France	Clinical Investigation center	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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