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Real World Study With Benralizumab in Severe Asthma in Switzerland

CompletedN/A

Sponsor: AstraZeneca

Conditions: Severe Eosinophilic Asthma

Countries: Switzerland

BEEPS describes the utility of patient reported outcomes (PRO) as simple, pragmatic, and sensitive tool to assess early treatment response of benralizumab to document the level of asthma control and change in medication after 1 to 16 weeks post-treatment initiation including use of OCS. The generated data on the time of asthma symptom relief after initiation of benralizumab will support patient management for a better disease control in severe asthma patients under benralizumab treatment. To assess long term outcomes the patients will have a last mandatory visit after 56 weeks, with no visits scheduled between week 16 and 56.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Swiss label must meet all the following criteria:

1. Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma according to ATS/ERS guidelines.
2. Asthma requiring high-dose ICS plus LABA as maintenance treatment.
3. Minimum of 2 exacerbations in the last 12 months.
4. Documented peripheral blood eosinophil count ≥ 300 cells/μL blood.
5. Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation in the study.
6. Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol (ACQ-5, PGI-C and PGI-S).

Exclusion Criteria:

Subjects meeting any of the following criteria will not be eligible to participate in the study:

1. Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
2. Currently enrolled in an interventional clinical study in parallel, except:

* Patients being in parallel documented in a national asthma registry.
* Patients having completed any other clinical trial including those with biologic treatment.
3. An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires or participate in this study or impact the interpretations of results.

Locations (12)

Aathal, Switzerland
Basel, Switzerland
Bern, Switzerland
Chur, Switzerland
Geneva, Switzerland
Liestal, Switzerland
Lucerne, Switzerland
Sion, Switzerland
Wetzikon, Switzerland
Zurich, Switzerland
Zurich, Switzerland
Zurich, Switzerland