Primary Nasal Cell Culture as a Tool for Personalized Therapy in Cystic Fibrosis

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

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-01

Study Completion Date

2016-03-03

Brief Summary

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characterization of CFTR function and expression in nasal primary cells collected from patients with cystic fibrosis in comparison to their parents, healthy heterozygotes and healthy controls

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Detailed Description

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3 groups of subjects are enrolled CF subjects according to their genotypes (aiming to enroll patients carrying 2 CF causing mutations with no CFTR expression/function, and patients carrying at least 1 mutation with residual function, such R117H) Parents or siblings of the CF subjects, as healthy hétérozygotes healthy controls All these subjects experience nasal brushings. From these nasal brushings,nasal cells are expanded, and cultured in air liquid interface to obtain polarized epithelium. This epithelium is then studied in Ussing chamber experiments to characterize the level of cAMP dependant Chloride transport and Sodium reabsorption. Apical expression of CFTR is assessed by immunofluorescence.

Results will allow to define the variability of CFTR function and expression criteria in subjects with the same genotype. Such data are crucial for interpretation of the effect of CFTR modulators.

Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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cystic fibrosis patients

Cystic fibrosis patients carrying to 2 CFTR mutations undergoing cell sampling

cell sampling

Intervention Type PROCEDURE

nasal brushing to collect cells

healthy heterozygotes

healthy heterozygotes carrying 1 CFTR mutations undergoing cell sampling

cell sampling

Intervention Type PROCEDURE

nasal brushing to collect cells

healthy control

subject with no evidence of any symptoms compatible with Cystic Fibrosis undergoing cell sampling

cell sampling

Intervention Type PROCEDURE

nasal brushing to collect cells

Interventions

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cell sampling

nasal brushing to collect cells

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with Cystic Fibrosis with 2 mutations in CFTR
* healthy heterozygotes with 1 mutation in CFTR
* healthy subjects with no familial history of Cystic Fibrosis and no symptoms suggesting Cystic Fibrosis