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Action of Epigenetic Modifiers in Cystic Fibrosis Treatment (Mod2EpiCF)

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ClinicalTrials.gov Identifier: NCT01883284
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Healthy Subjects Other: Tests in vitro after sampling nasal cells of CF patients or controls Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

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

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.
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.



Primary Outcome Measures :
  1. Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Pro-inflammatory cytokines number variations after epigenetic modifiers treatment [ Time Frame: 24 months ]
  2. Anti-inflammatory cytokines number variations after epigenetic modifiers treatment [ Time Frame: 24 months ]
  3. Mucin composition variations after epigenetic modifiers treatment [ Time Frame: 24 months ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01883284


Locations
France
Respiratory Diseases Department
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Raphaël RC CHIRON, MD Arnaud de Villeneuve CHU Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01883284     History of Changes
Other Study ID Numbers: 8870
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

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