Functional Analysis by Dynamic Imaging of the Respiratory Epithelium in Infants With Cystic Fibrosis
|ClinicalTrials.gov Identifier: NCT01605565|
Recruitment Status : Unknown
Verified May 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Recruiting
First Posted : May 25, 2012
Last Update Posted : May 25, 2012
|Condition or disease||Intervention/treatment|
|Cystic Fibrosis||Procedure: A nasal brushing|
Cystic fibrosis (CF) is characterized by airway inflammation and infection leading to progressive destruction of lungs. One of the most important abnormalities in CF is an abnormal processing of the mutated CFTR protein through the endoplasmic reticulum that causes abnormal location or even absence of the protein at the apical plasma membrane of airway epithelial cells. This abnormality results in a marked dehydration of the airway surface fluid, decreased mucus transport and airway obstruction. Nevertheless, the events that occur very early during the progression of the disease at the airway level in infants are not known. At cellular level, it has also been reported that the CFTR expression and localization could be related to the differentiation state of the airway epithelium. Furthermore, it has been reported that gap junctions could be involved in dysregulate inflammation process. In CF infants, many answers are still lacking.
Is inflammation present before infection? Is native epithelium of CF infants more sensitive than controls? Could the investigators analyse the localisation and functionality of CFTR, tight and gap junctions in respiratory epithelial cells in CF infants? Could the activation of the epithelial cells by bacteria alter their functional properties? For a better understanding of the early stages of cystic fibrosis, it is of major interest to study respiratory epithelial cells obtained as early as possible. Although bronchoalveolar lavage has been proposed for this purpose, nasal brushing, which is a much less invasive technique, has seldom been used in CF infants. the investigators have shown that, by means of a simple nasal brushing technique easily performed and well tolerated, it is feasible, in infants, to harvest native respiratory cell sheets in order to analyse the airway epithelium functionality. In 15 CF infants and 15 control infants, a nasal brushing will be performed by means of a soft sterile cytology brush. Samples will be used for cytological and functional studies: ciliary beating frequency, cAMP-dependent chloride efflux, potassium efflux, tight and gap junctions functionalities. These studies will be done in basal conditions and will be repeated after activation of the nasal epithelial cells by the bacteria, such as Staphylococcus aureus, which can be found very early in the course of CF disease.
the investigators believe that the present study could help to understand the pathophysiology on the very early stages of CF disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Analyse Fonctionnelle Par Imagerie Dynamique de l'épithélium Respiratoire Chez Des Nourrissons Atteints de Mucoviscidose|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||November 2014|
Procedure: A nasal brushing
- The main objective is to analyze the functionality of the respiratory epithelium in CF infant using a nasal brushing technique: ciliary beating frequency, cAMP-dependent chloride efflux, potassium efflux, tight and gap junctions functionalities. [ Time Frame: no time frame ]In 15 CF infants and 15 control infants, a nasal brushing will be performed by means of a soft sterile cytology brush. Samples will be used for cytological and functional studies: ciliary beating frequency, cAMP-dependent chloride efflux, potassium efflux, tight and gap junctions functionalities.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605565
|Contact: Michel ABELY, Professor||+333 email@example.com|
|Reims, France, 51092|
|Contact: MICHEL ABELY, Professor +333326787007 firstname.lastname@example.org|
|Principal Investigator: Michel ABELY, Professor|
|Principal Investigator:||Michel ABELY, Professor||CHU REIMS|