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Action of Epigenetic Modifiers in Cystic Fibrosis Treatment

NCT ID: NCT01883284

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Cystic Fibrosis Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cystic Fibrosis patients (CF)

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Control subjects (non CF)

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

Group Type OTHER

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* informed consent
* benefit from disease insurance regimen
* men and women


* 2 severe CF mutations
* age superior or equal to 12


* age superior or equal to 18
* no smoker (for 5 years)

Exclusion Criteria

* participation to an other interventionnal study
* subject in exclusion period
* law protected subject
* pregnant and breast fooding


* Xylocaine hypersensibility
* Porphyria
* severe hepatic failure
* Epilepsy
* Severe cardiac failure
* local anesthesic contra indication


* respiratory disease
* cystic fibrosis
* acute infection \< 6 weeks
* on treatment
* antibiotic treatment \< 3 months
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphaël RC CHIRON, MD

Role: PRINCIPAL_INVESTIGATOR

Arnaud de Villeneuve CHU Montpellier

Locations

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Respiratory Diseases Department

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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8870

Identifier Type: -

Identifier Source: org_study_id