Prediction of benralizumab response in severe asthma using clinical parameters and early treatment response: a national, real life study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27637

Enrollment

200

Registered

2020-09-09

Start date

2020-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

Benralizumab 30 mg as per protocol. This is a real-world trial, so the intervention happens regardless of this trial.

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Included in RAPSODI, receiving benralizumab treatment RAPSODI inclusion criteria: - Severe asthma patient in the Netherlands - =18 years old

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
Benralizumab response is the main endpoint. Benralizumab response will be defined as continuing benralizumab at the 1 year point. A multivariable model based on (changes in) 3 month patient reported outcome measures and baseline characteristics will be constructed, predicting benralizumab response in severe asthma patients.	—

Secondary

Measure	Time frame
Change in the model’s performance (f.e. AUROC, predictive values) by adding the 3 month patient reported outcome measures will be assessed and reported.	—

Contacts

Public ContactHans Kroes

Medisch Centrum Leeuwarden

hans.kroes1@znb.nl0582861837

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)