Action of Epigenetic Modifiers in Cystic Fibrosis Treatment (Mod2EpiCF)

December 2, 2014 updated by: University Hospital, Montpellier

Action of Epigenetic Modifiers in Cystic Fibrosis Treatment: ex Vivo Model of Nasal Epithelium of CF Patients

Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4 and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using an air-liquide interface culture of nasals cells from CF patients or controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Respiratory Diseases Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

General inclusion criteria :

  • informed consent
  • benefit from disease insurance regimen
  • men and women

Inclusion Criteria for CF patients

  • 2 severe CF mutations
  • age superior or equal to 12

Inclusion Criteria for controls :

  • age superior or equal to 18
  • no smoker (for 5 years)

General exclusion criteria :

  • participation to an other interventionnal study
  • subject in exclusion period
  • law protected subject
  • pregnant and breast fooding

Specific Exclusion Criteria:

  • Xylocaine hypersensibility
  • Porphyria
  • severe hepatic failure
  • Epilepsy
  • Severe cardiac failure
  • local anesthesic contra indication

Specific Control subject Exclusion Criteria:

  • respiratory disease
  • cystic fibrosis
  • acute infection < 6 weeks
  • on treatment
  • antibiotic treatment < 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cystic Fibrosis patients (CF)
Tests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects
Other: Tests in vitro after sampling nasal cells of CF patients or controls
Nasal cells of CF patients or controls were collected by scratching of intermediate turbinate and cultured in vitro. Epigenetic modifiers treatment was applied to these ex vivo nasal epithelia. Then, mRNA, protein and secretions were quantified.
Other: Control subjects (non CF)
Tests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects
Other: Tests in vitro after sampling nasal cells of CF patients or controls
Nasal cells of CF patients or controls were collected by scratching of intermediate turbinate and cultured in vitro. Epigenetic modifiers treatment was applied to these ex vivo nasal epithelia. Then, mRNA, protein and secretions were quantified.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pro-inflammatory cytokines number variations after epigenetic modifiers treatment
Time Frame: 24 months
24 months
Anti-inflammatory cytokines number variations after epigenetic modifiers treatment
Time Frame: 24 months
24 months
Mucin composition variations after epigenetic modifiers treatment
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Raphaël RC CHIRON, MD, Arnaud de Villeneuve CHU Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8870

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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