Retrospective, Observational, Portuguese Hospitals to Describe Patient Characteristics, Treatment Patterns and Outcomes

Completed

• Conditions: Severe Asthma

• Registration Number: NCT07159295
• Lead Sponsor: AstraZeneca

Brief 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 descriptive, observational, multi-centre, longitudinal, retrospective cohort study in 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

Study Timeline

• Study Start: 2021-08-10
• Primary Completion: 2022-11-03
• Study Completion: 2022-11-03
• Status Verified: 2025-08
• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Adults patients with severe asthma treated with benralizumab, who had their first benralizumab dose between July 2019 and October 2020

  • Patients who have at least 1 benralizumab injection and with at least 3 months followup data from the first injection.
  • Give voluntary signed informed consent

Exclusion Criteria

• Currently receiving benralizumab or any other biologic drug for the treatment of asthma in a clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe baseline demographic and clinical chareacteristics of severe eosinophilic asthma patients treated with benralizumab	baseline, 12 and 24 months	Crucial need in Portugal to provide key real -word evidence on benralizumab therapy

Trial Locations

Locations (15)

Hospital Prof. Dr. Fernando Fonseca; 🇵🇹 Amadora, Portugal

HSMM; 🇵🇹 Barcelos, Portugal

CHUC - Imunoalergologia; 🇵🇹 Coimbra, Portugal

CHUC - Pneumologia; 🇵🇹 Coimbra, Portugal

CHUA; 🇵🇹 Portimão, Portugal

Hospital Leiria; 🇵🇹 Leiria, Portugal

Chln - Hsm; 🇵🇹 Lisbon, Portugal

Chuln - Hsm; 🇵🇹 Lisbon, Portugal

Hospital Pedro Hispano; 🇵🇹 Matosinhos Municipality, Portugal

CHUSJ - Imuno; 🇵🇹 Porto, Portugal

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