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

Completed

• Conditions: Severe Eosinophilic Asthma

• Registration Number: NCT04126499
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-15
• Study Start: 2020-01-13
• Primary Completion: 2020-05-08
• Study Completion: 2020-05-08
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-24
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sex	Up to 32 weeks	Male, Female
Body Mass Index (BMI)	Up to 32 weeks	Weight and height will be combined to report BMI in kg/m\^2
Age at onset of asthma diagnosis	Up to 32 weeks	Age (years)
Age	Up to 32 weeks	Age (years)
Smoking status	Up to 32 weeks	Current smoker, Ex-smoker, Never smoker
Comorbidities	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	Up to 32 weeks	Number of hospitalizations
Unscheduled visits	Up to 32 weeks	Number of unscheduled visits
Severe exacerbations	Up to 32 weeks	Severe exacerbations in past 12 months: number and severity
Emergency room (ER) visits	Up to 32 weeks	Number of ER visits
ACT	Up to 32 weeks	ACT questionnaire score
Blood eosinophils	Up to 32 weeks	Blood eosinophils count (cells/microL)
miniAQLQ	Up to 32 weeks	miniAQLQ questionnaire score

Secondary Outcome Measures

Name	Time	Method
Incidence of severe exacerbations	Up to 32 weeks	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.

Trial Locations

Locations (1)

BIG PAC; 🇪🇸 Madrid, Spain