Observational Retrospective Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Eosinophilic Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Sex
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Sex
Time Frame: Up to 32 weeks
Male, Female
Body Mass Index (BMI)
Time Frame: Up to 32 weeks
Weight and height will be combined to report BMI in kg/m\^2
Age at onset of asthma diagnosis
Time Frame: Up to 32 weeks
Age (years)
Age
Time Frame: Up to 32 weeks
Age (years)
Smoking status
Time Frame: Up to 32 weeks
Current smoker, Ex-smoker, Never smoker
Comorbidities
Time Frame: Up to 32 weeks
Multiple response (binomial): allergies, nasal polyposis, rhinitis, GERD, atopic dermatitis, condition related with chronic OCS use, other eosinophilic driven diseases
Hospitalizations
Time Frame: Up to 32 weeks
Number of hospitalizations
Unscheduled visits
Time Frame: Up to 32 weeks
Number of unscheduled visits
Severe exacerbations
Time Frame: Up to 32 weeks
Severe exacerbations in past 12 months: number and severity
Emergency room (ER) visits
Time Frame: Up to 32 weeks
Number of ER visits
ACT
Time Frame: Up to 32 weeks
ACT questionnaire score
Blood eosinophils
Time Frame: Up to 32 weeks
Blood eosinophils count (cells/microL)
miniAQLQ
Time Frame: Up to 32 weeks
miniAQLQ questionnaire score
Secondary Outcomes
- Incidence of severe exacerbations(Up to 32 weeks)