Action of Epigenetic Modifiers in Cystic Fibrosis Treatment

Cystic Fibrosis Clinical Trial

— Mod2EpiCF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883284
• Other study ID #: 8870
• Status: Completed
• Phase: N/A
• First received: June 13, 2013
• Last updated: December 2, 2014
• Start date: January 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Healthy Subjects

Intervention

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.

Locations

Country	Name	City	State
France	Respiratory Diseases Department	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment		24 months	No
Secondary	Pro-inflammatory cytokines number variations after epigenetic modifiers treatment		24 months	No
Secondary	Anti-inflammatory cytokines number variations after epigenetic modifiers treatment		24 months	No
Secondary	Mucin composition variations after epigenetic modifiers treatment		24 months	No