Action of Epigenetic Modifiers in Cystic Fibrosis Treatment

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Healthy Subjects
• Interventions: Other: Tests in vitro after sampling nasal cells of CF patients or controls

• Registration Number: NCT01883284
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-21
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystic Fibrosis patients (CF)	Tests in vitro after sampling nasal cells of CF patients or controls	Tests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects
Control subjects (non CF)	Tests in vitro after sampling nasal cells of CF patients or controls	Tests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects

Primary Outcome Measures

Name	Time	Method
Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment	24 months

Secondary Outcome Measures

Name	Time	Method
Mucin composition variations after epigenetic modifiers treatment	24 months
Pro-inflammatory cytokines number variations after epigenetic modifiers treatment	24 months
Anti-inflammatory cytokines number variations after epigenetic modifiers treatment	24 months

Trial Locations

Locations (1)

Respiratory Diseases Department; 🇫🇷 Montpellier, France