Induction of Neutrophilic Traps ( NETs ) by the Environment and Infectious Inflammatory Lung Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— MucoNETs  

Official title:

Secretion Induction of Neutrophil Extracellular Traps (NETs)in Inflammatory and Infectious Environment of Mucoviscidose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564393
• Other study ID #: PHAO09-PD / MucoNETs
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2015
• Last updated: September 29, 2015
• Start date: May 2011

Study information

• Verified date: September 2015
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The study is defined in 3 stages of in vitro assays :

Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors.

This is a transversal study in which we compare :

• Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of patients

• Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients and blood of control subjects

Phase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent transduction pathways calcium and PKC . It will be performed on control blood neutrophils.

Phase 3: Analysis of cell death ( NETose )

This is a transversal study that will analyze :

the mode of cell death of neutrophils purified blood and sputum of patients and control blood neutrophils by flow cytometry and transmission electron microscopy .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients :

• Men or women over 18

• Patients with mucoviscidose in stable condition, i.e. not having presented an acute push of bronchopulmonary attack requiring a antibiothérapie or a hospitalization for treatment of its disease during the 2 previous weeks

• Signed consent

Volunteers :

• Men or women over 18

• Without respiratory antecedent nor known respiratory pathology

• Signed consent

Exclusion Criteria:

Patients :

• In exclusion period of an other study

Volunteers :

• In exclusion period of an other study

• Antibiotic treatment and/or anti-inflammatory drug (AINS or corticoids) in the 2 weeks before inclusion in the study

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
France	CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the DNA concentration secreted into the extracellular environment neutrophil activated		1 hour	No