Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University Hospital, Lille
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01329172
First received: May 21, 2010
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Dietary Modification
Other: polyunsaturated fatty acids n-3
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

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 [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]

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 [ Time Frame: baseline and two months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PUFA n-3
Placebo Comparator: placebo
sun flower oil
Other: placebo
sun flower oil with Poly Unsaturated Fatty Acid 1g/day
Other Name: PUFA

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

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 )
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329172

Contacts
Contact: Frédéric GOTTRAND, MD, PhD frederic.gottrand@chru-lille.fr

Locations
France
Dunkerque Hospital Recruiting
Dunkerque, France
Contact: Guy-André LOEUILLE, MD, PhD       Guy-andre.loeuille@ch-dunkerque.fr   
Lens Hospital Recruiting
Lens, France, 62300
Contact: Anne SARDET, MD, PhD       asardet@ch-lens.fr   
Clinical Investigation center Recruiting
Lille, France, 59037
Contact: Frédéric GOTTRAND, MD-PhD    +33 3 20 44 68 91    frederic.gottrand@chru-lille.fr   
Contact: Laurent BEGHIN, PhD    +33 3 20 44 68 91    laurent.beghin@chru-lille.fr   
Sub-Investigator: MORTUAIRE Geoffrey, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Study Chair: Frédéric GOTTRAND, MD, PhD CHRU de Lille et Université Lille 2
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01329172     History of Changes
Other Study ID Numbers: 2008_47/0928, 2009-014869-43
Study First Received: May 21, 2010
Last Updated: November 6, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Lille:
PUFA
Cystic Fibrosis
Nasal brushing
Mucins
Mucin production

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014