Action of Epigenetic Modifiers in Cystic Fibrosis Treatment: ex Vivo Model of Nasal Epithelium of CF Patients (Mod2EpiCF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01883284
First received: June 13, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Healthy Subjects
Other: Tests in vitro after sampling nasal cells of CF patients or controls

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Action of Epigenetic Modifiers in Cystic Fibrosis Treatment: ex Vivo Model of Nasal Epithelium of CF Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pro-inflammatory cytokines number variations after epigenetic modifiers treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Anti-inflammatory cytokines number variations after epigenetic modifiers treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mucin composition variations after epigenetic modifiers treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01883284

Contacts
Contact: Nicolas MOLINARI, PhD (+33)467338979 nicolas.molinari@inserm.fr

Locations
France
Respiratory Diseases Department Recruiting
Montpellier, France, 34295
Contact: Raphaël CHIRON, MD    (+33)467336089    r-chiron@chu-montpellier.fr   
Contact: Anne BERGOUGNOUX, PhD    (+33)411759879    anne.bergougnoux@inserm.Fr   
Principal Investigator: Raphaël RC CHIRON, MD         
Sub-Investigator: Arnaud AB BOURDIN, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Raphaël RC CHIRON, MD Arnaud de Villeneuve CHU Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01883284     History of Changes
Other Study ID Numbers: 8870
Study First Received: June 13, 2013
Last Updated: June 20, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by University Hospital, Montpellier:
Cystic Fibrosis
nasal epithelia
mucins

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

ClinicalTrials.gov processed this record on September 18, 2014