Cystic Fibrosis Clinical Trial
— Mod2EpiCFOfficial title:
Action of Epigenetic Modifiers in Cystic Fibrosis Treatment: ex Vivo Model of Nasal Epithelium of CF Patients
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.
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
France | Respiratory Diseases Department | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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 |
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