NCT04126499

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2020-01-13
• Primary completion: 2020-05-08
• Completion: 2020-05-08
• First posted: 2019-10-15
• Last updated: 2021-06-29

Locations

1 site across 1 country: Spain