ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01329172
Recruitment Status : Terminated
First Posted : April 5, 2011
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Modification Other: polyunsaturated fatty acids n-3 Other: placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients
Actual Study Start Date : September 20, 2010
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329172


Locations
France
Dunkerque Hospital
Dunkerque, France
Lens Hospital
Lens, France, 62300
Clinical Investigation center
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Study Chair: Frédéric GOTTRAND, MD, PhD CHRU de Lille et Université Lille 2

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01329172     History of Changes
Other Study ID Numbers: 2008_47/0928
2009-014869-43 ( EudraCT Number )
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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