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Completed

NCT Number: NCT01883284

Action of Epigenetic Modifiers in Cystic Fibrosis Treatment

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Healthy Subjects Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory Diseases Department

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment

    Time frame: 24 months

Secondary outcomes

  1. Pro-inflammatory cytokines number variations after epigenetic modifiers treatment

    Time frame: 24 months

  2. Anti-inflammatory cytokines number variations after epigenetic modifiers treatment

    Time frame: 24 months

  3. Mucin composition variations after epigenetic modifiers treatment

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: Mod2EpiCF

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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