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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cystic Fibrosis; Dietary Modification
• Intervention / Treatment: Other: polyunsaturated fatty acids n-3; Other: placebo

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dunkerque, France
    • Dunkerque Hospital
  • Lens, France, 62300
    • Lens Hospital
  • Lille, France, 59037
    • Clinical Investigation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Study Chair: Frédéric GOTTRAND, MD, PhD, CHRU de Lille et Université Lille 2

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2010
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: May 21, 2010
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (Estimate): April 5, 2011

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; PUFA; Nasal brushing; Mucins; Mucin production
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 2008_47/0928; 2009-014869-43 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No