Action of Epigenetic Modifiers in Cystic Fibrosis Treatment

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01883284

Acronym

Mod2EpiCF

Enrollment

Registered

2013-06-21

Start date

2012-01-31

Completion date

2014-11-30

Last updated

2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Healthy Subjects

Keywords

Cystic Fibrosis, nasal epithelia, mucins

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.

Interventions

OTHERTests 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment	24 months

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026