ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab (ANANKE)

AstraZeneca

Status: Completed

Conditions: Severe Asthma

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04272463

D3250R00073

Details and patient eligibility

About

This is an observational, Italian multi-center, retrospective cohort study with enrollment visit on patients suffering from severe eosinophilic asthma who started benralizumab in the Sampling Program or as per normal clinical practice in Italy.

Full description

A retrospective cohort study design involving secondary data collection was chosen to appropriately address the primary objective in a relatively short period of time after enrollment phase initiation: in fact, since the Italian Sampling Program on benralizumab was active since July 2018, clinical data on patients exposed to benralizumab are already available. No treatments will be administered per protocol requirement, but instead according to normal clinical practice; since benralizumab first administration occurs before inclusion in the study (as per chosen study design), the decision to include the patient in the study is clearly separated from the prescription of benralizumab, in accordance with the observational nature of the study. In order to be eligible for the study, for each patient, the index date shall be at least 3 months prior to enrollment.

Enrollment: 217 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients (age ≥18 years) at the start of benralizumab treatment within the sampling program or per clinical practice ("index date").
2. Patients with severe eosinophilic asthma requiring a stable treatment of high doses of inhaled corticosteroids and a long acting β2 agonist ± additional asthma controller (according to clinician's judgment).
3. Patients who started benralizumab and received at least one injection at least 3 months before enrollment, either within the sampling program or as per routine clinical practice.
4. Patients who signed the informed consent and privacy form at enrollment visit.
5. Patients with available hospital medical chart since the start of benralizumab treatment within the sampling program or per clinical practice ("index date").

Exclusion criteria

1. Patients who, during the observation period, received benralizumab in a clinical experimental trial.
2. Patients who, during the observation period, participated in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.