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Effect of Benralizumab on Airway Remodeling in Asthma

NCT04365205 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-02-06

No results posted yet for this study

Summary

The anti-interleukin (IL)-5 receptor benralizumab inhibits eosinophilic inflammation but its potential effect on airway remodeling remains unknown. The main objective of this study is to assess the effect of benralizumab in an in vitro model of airway remodeling using cells obtained from asthmatic patients.

Conditions

Interventions

PROCEDURE

Endobronchial biopsy

Endobronchial biopsies will be collected following a standardized procedure based on established guidelines. Before the procedure, asthmatic subjects will receive 400 μg of salbutamol with the aid of an aerosol chamber to open up the airways before the procedure. Anesthesia of the upper airways will be achieved with lidocaine 5% spray. The total amount of lidocaine per subject is limited to 225 mg. General anesthesia will be obtained using propofol (average dose of 1.5 to 2 mg/kg). The fiberoptic bronchoscope (Pentax BF 15V, Argenteuil, France) is introduced and 8 to 10 biopsies will be taken from the middle lobe and the lower right lobe. Standard procedures such as bronchial brushing and bronchial fluid aspiration will also be performed. The duration of bronchoscopy is 15 minutes to 30 minutes. After the procedures, subjects will receive a short acting bronchodilator if required.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Pierre-Olivier GIRODET, MD, PhD · University Hospital, Bordeaux

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2024-10-05
Completion
2024-10-05

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365205 on ClinicalTrials.gov