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

NCT04126499 | Completed

• 1 other identifier: D3250R00052
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Eosinophilic Asthma

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (1)

• Incidence of severe exacerbations

  Up to 32 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients enrolled in a clinical trial who received benralizumab during the same period of the individualized access program
• Refuse to sign the informed consent

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

BIG PAC

Madrid, Spain

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 15, 2019
• Study Start: January 13, 2020
• Primary Completion: May 8, 2020
• Study Completion: May 8, 2020
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

ES (1)