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

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

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 Overview

• Status: Completed
• Conditions: Severe Eosinophilic Asthma

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • BIG PAC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be all patients who received at least one dose of benralizumab in individualized access program approved by the AEMPS.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): May 8, 2020
• Study Completion (Actual): May 8, 2020

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Hematologic Diseases; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Pulmonary Eosinophilia
• Other Study ID Numbers: D3250R00052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No