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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Age | Age (years) | Up to 32 weeks |
| Sex | Male, Female | Up to 32 weeks |
| Body Mass Index (BMI) | Weight and height will be combined to report BMI in kg/m^2 | Up to 32 weeks |
| Smoking status | Current smoker, Ex-smoker, Never smoker | Up to 32 weeks |
| Age at onset of asthma diagnosis | Age (years) | 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 | Up to 32 weeks |
| Severe exacerbations | Severe exacerbations in past 12 months: number and severity | Up to 32 weeks |
| Emergency room (ER) visits | Number of ER visits | Up to 32 weeks |
| Hospitalizations |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 32 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be all patients who received at least one dose of benralizumab in individualized access program approved by the AEMPS.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIG PAC | Madrid | Spain |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D011657 | Pulmonary Eosinophilia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
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Number of hospitalizations
| Up to 32 weeks |
| Unscheduled visits | Number of unscheduled visits | Up to 32 weeks |
| ACT | ACT questionnaire score | Up to 32 weeks |
| miniAQLQ | miniAQLQ questionnaire score | Up to 32 weeks |
| Blood eosinophils | Blood eosinophils count (cells/microL) | Up to 32 weeks |
| D007960 |
| Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |