Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
63

Summary

Conditions
Asthma
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

Patients will be openly labeled in one of the following group 15 patients with severe asthma, without oral corticosteroids treatment., 6 patients with mild to moderate asthma without treatment, 21 controlled samples from smooth muscle cells of non-asthmatic deceased donor Bronchial endoscopy with br...

Patients will be openly labeled in one of the following group 15 patients with severe asthma, without oral corticosteroids treatment., 6 patients with mild to moderate asthma without treatment, 21 controlled samples from smooth muscle cells of non-asthmatic deceased donor Bronchial endoscopy with bronchial biopsies will be assessed in all asthmatic patients, Control samples will be obtained from tracheobronchial rings of cadaveric donor. Expression and activity of Rac1 in airway smooth muscle will be determined by immuno-staining on paraffinised biopsies. Patients will undergo two study visits (D0: inclusion visit, D15: exploratory visit) and one phone call at D21. Inclusion Visit (D0): Signature of the Informed consent, Medical History, Clinical examination, Pulmonary Function Test, Blood samples for fibroscopy safety, ACT (Asthma Control Test), ACQ (Asthma Control Questionnaire), AQLQ (Asthma Quality of Life Questionnaire), Morisky questionnaire Exploratory visit (D15) Clinical examination, Bronchial endoscopy with biopsies Adverse event Phone Call (D21) - Adverse event Recruitment will last 4 years.

Tracking Information

NCT #
NCT03325088
Collaborators
  • L'institut du thorax - INSERM UMR 1087 / CNRS UMR6291 - IRS-Université de Nantes
  • IRSR-PL : Institut de Recherche en Santé Respiratoire des Pays de La Loire
Investigators
Not Provided