Action of Epigenetic Modifiers in Cystic Fibrosis Treatment (Mod2EpiCF)

University Hospital Center (CHU)

Status: Completed

Conditions: Healthy Subjects; Cystic Fibrosis

Treatments: Other: Tests in vitro after sampling nasal cells of CF patients or controls

Study type: Interventional

Funder types: Other

Identifiers

NCT01883284

8870

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Cystic Fibrosis patients (CF)

Experimental group

Description:

Tests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects

Treatment:

Other: Tests in vitro after sampling nasal cells of CF patients or controls

Control subjects (non CF)

Other group

Description:

Tests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects

Treatment:

Other: Tests in vitro after sampling nasal cells of CF patients or controls