NCT04365205

Effect of Benralizumab on Airway Remodeling in Asthma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Sixty subjects will be recruited: 20 patients with severe asthma patients, 20 patients with non-severe asthma and 20 non-asthmatic controls. Inclusion visit will include written informed consent, asthma questionnaire, clinical examination, lung function testing, prick tests and assessment of airway remodeling using CT scan and MRI. Bronchial specimens from all subjects will be obtained by fiberoptic bronchoscopy. Airway remodeling will be evaluated by morphological analysis. After BSM cell culture, BSM cells function will be assessed in vitro in the absence or presence of benralizumab using proliferation (BrdU) and chemotactism experiments, ELISA, RT-PCR (polymerase chain reaction ) and electronic microscopy.

Conditions

• Asthma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-23
• Primary completion: 2024-10-05
• Completion: 2024-10-05
• First posted: 2020-04-28
• Last updated: 2024-02-06

Locations

1 site across 1 country: France