Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain

AstraZeneca28 enrolled

Overview

Observational, retrospective study in adults (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who at the discretion of the investigator were candidates to receive benralizumab in the individualized access program approved by national health authorities. Primary Objective: To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma who participated in the individualized access program approved in Spain and received at least one dose of benralizumab. Secondary Objectives: To describe clinical outcomes in severe eosinophilic asthma patients who received at least three doses of benralizumab in the individualized access program.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Severe Eosinophilic Asthma

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients (age ≥18 years) * Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller * Received at least one dose of benralizumab during the individualized access program period (March-December of 2018) * Informed consent signed Exclusion Criteria: * Patients enrolled in a clinical trial who received benralizumab during the same period of the individualized access program * Refuse to sign the informed consent

Locations (1)

Outcomes

Primary Outcomes

Age

Age (years)

Time frame: Up to 32 weeks

Sex

Male, Female

Time frame: Up to 32 weeks

Body Mass Index (BMI)

Weight and height will be combined to report BMI in kg/m\^2

Time frame: Up to 32 weeks

Smoking status

Current smoker, Ex-smoker, Never smoker

Time frame: Up to 32 weeks

Age at onset of asthma diagnosis

Age (years)

Time frame: Up to 32 weeks

Comorbidities

Multiple response (binomial): allergies, nasal polyposis, rhinitis, GERD, atopic dermatitis, condition related with chronic OCS use, other eosinophilic driven diseases

Time frame: Up to 32 weeks

Severe exacerbations

Severe exacerbations in past 12 months: number and severity

Time frame: Up to 32 weeks

Emergency room (ER) visits

Number of ER visits

Time frame: Up to 32 weeks

Hospitalizations

Number of hospitalizations

Time frame: Up to 32 weeks

Unscheduled visits

Number of unscheduled visits

Time frame: Up to 32 weeks

ACT

ACT questionnaire score

Time frame: Up to 32 weeks

miniAQLQ

miniAQLQ questionnaire score

Time frame: Up to 32 weeks

Blood eosinophils

Blood eosinophils count (cells/microL)

Time frame: Up to 32 weeks

Secondary Outcomes

Incidence of severe exacerbations

The incidence rate for any severe exacerbations in each calendar year will be calculated as follows: the sum of any severe exacerbations in that year divided by the total duration of follow-up in the same calendar year.

Time frame: Up to 32 weeks