Asthma Asthma
Conditions
Interventions
The immuno-OCT and PS-OCT probe, connected to the immuno-PS-OCT system are subsequently inserted into the working channel of the bronchoscope until the far periphery of the lungs and then manually pul
Investigational Medical Device Dossier (IMDD). 
Benralizumab-IRDYE-800CW fluorescent tracer will be used in this study as an auxiliary medicinal product in asthma patients with a clinical indication for benralizumab treatmentBenralizumab (Fasenra)
IRDye800CW is a near-infrared organic fluorophore, developed by Li-COR Biosciences (USA). Conjugation of the fluorescent dye to benralizumab, purification and formulation will be performed at the depa
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with the age of 18 years or older with severe asthma and who are eligible for treatment with benralizumab (B-eos = 150 cell/µL or = 300 cell/µL*, B-eos = 150 cell/µL if treated with oral corticosteroids Or sputum eosinophils >2% unrelated with or without OCS) and are included in the AIR-BIO-OCT study.
Exclusion criteria
Exclusion criteria: Known allergy to benralizumab or Li-Cor IRDYE 800CWPatient has been treated with a biologic for severe asthma in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of imaging benralizumab-800CW in vivo using immuno-OCT signal with dose escalation: measurement of fluorescent signal in the airways of patients who have been given the benralizumab-800CW tracer compared to patients who did not receive the tracer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives consist of:To increase understanding of benralizumab in the body by analysing the different compartments: Airway wall Bronchoalveolar fluid BloodTo increase understanding of cellular targets of benralizumab in the airway wall, bronchoalveolar fluid, and blood. | — |
Countries
Netherlands
Contacts
Public ContactL Nicolai
Amsterdam UMC
Outcome results
None listed