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

Primary Purpose

Cystic Fibrosis, Dietary Modification

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
polyunsaturated fatty acids n-3
placebo
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring PUFA, Cystic Fibrosis, Nasal brushing, Mucins, Mucin production

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept 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 )

Sites / Locations

  • Dunkerque Hospital
  • Lens Hospital
  • Clinical Investigation center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

polyunsaturated fatty acids n-3

placebo

Arm Description

polyunsaturated fatty acids n-3 (PUFA n-3)

sun flower oil

Outcomes

Primary Outcome Measures

Expression of Mucin "MUC5B" by measurement of messenger Ribo Nucleic Acid (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

Full Information

First Posted
May 21, 2010
Last Updated
December 21, 2017
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT01329172
Brief Title
Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients
Acronym
NOSTRIL
Official Title
Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Study Start Date
September 20, 2010 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Dietary Modification
Keywords
PUFA, Cystic Fibrosis, Nasal brushing, Mucins, Mucin production

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polyunsaturated fatty acids n-3
Arm Type
Experimental
Arm Description
polyunsaturated fatty acids n-3 (PUFA n-3)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
sun flower oil
Intervention Type
Other
Intervention Name(s)
polyunsaturated fatty acids n-3
Other Intervention Name(s)
PUFA n-3
Intervention Description
polyunsaturated fatty acids n-3 1 gram per day during two months
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
PUFA
Intervention Description
sun flower oil with Poly Unsaturated Fatty Acid 1g/day
Primary Outcome Measure Information:
Title
Expression of Mucin "MUC5B" by measurement of messenger Ribo Nucleic Acid (mRNA) level in native airway epithelial cells obtained by nasal brushing
Time Frame
baseline and 2 months
Secondary Outcome Measure Information:
Title
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
Time Frame
baseline and two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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 )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric GOTTRAND, MD, PhD
Organizational Affiliation
CHRU de Lille et Université Lille 2
Official's Role
Study Chair
Facility Information:
Facility Name
Dunkerque Hospital
City
Dunkerque
Country
France
Facility Name
Lens Hospital
City
Lens
ZIP/Postal Code
62300
Country
France
Facility Name
Clinical Investigation center
City
Lille
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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