Clinical Trials Directory

Trials / Completed

CompletedNCT07159295

Study in Portuguese Hospitals to Describe Patient Characteristics, Treatment Patterns and Outcomes

Betreat (Xaloc1) Benralizumab Study: Retrospective, Observational Study in Portuguese Hospitals to Describe Patient Characteristics, Treatment Patterns and Outcomes

Status
Completed
Phase
Study type
Observational
Enrollment
74 (actual)
Sponsor
AstraZeneca · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Benralizumab is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β2-agonists. It has been reimbursed in Portugal as an add-on therapy since May 2019. In order of this, there is crucial need in Portugal to provide key real-word evidence on benralizumab therapy.

Detailed description

This is a real-world retrospective, multicentric, observational study, utilizing secondary data collection from medical records of adults patients (≥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 physician, received benralizumab accordingly to the clinical practice, in the period after the marketing authorization of benralizumab.

Conditions

Timeline

Start date
2021-08-10
Primary completion
2022-11-03
Completion
2022-11-03
First posted
2025-09-08
Last updated
2025-10-21

Locations

16 sites across 1 country: Portugal

Source: ClinicalTrials.gov record NCT07159295. Inclusion in this directory is not an endorsement.