Mod2EpiCF: Action of Epigenetic Modifiers in Cystic Fibrosis Treatment

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT01883284
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis; Healthy Subjects	Other: Tests in vitro after sampling nasal cells of CF patients or controls	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Action of Epigenetic Modifiers in Cystic Fibrosis Treatment: ex Vivo Model of Nasal Epithelium of CF Patients
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cystic Fibrosis patients (CF) Tests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects	Other: 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.
Other: Control subjects (non CF) Tests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment [24 months]

Secondary Outcome Measures

1. Pro-inflammatory cytokines number variations after epigenetic modifiers treatment [24 months]

2. Anti-inflammatory cytokines number variations after epigenetic modifiers treatment [24 months]

3. Mucin composition variations after epigenetic modifiers treatment [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Respiratory Diseases Department	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

• Principal Investigator: Raphaël RC CHIRON, MD, Arnaud de Villeneuve CHU Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT01883284
• Other Study ID Numbers: 8870
• First Posted: Jun 21, 2013
• Last Update Posted: Dec 3, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by University Hospital, Montpellier: Cystic Fibrosis; nasal epithelia; mucins
• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of Dec 3, 2014