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

NCT07159295 | Completed

• 1 other identifier: D3250R00088
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 16

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.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (2)

• Baseline demographic and clinical characteristics of severe eosinophilic asthma patients treated with benralizumab

  Demographic: Gender, age, BMI, smoking history Clinical: age of asthma diagnosis, ACT score, CARAT score, blood eosinophil count, FeNO, Lung function, FVC, Reversibility of FEV1, Total IgE in peripheral blood, Skin PRICK test

  Baseline/Index date

• Background treatment patterns of severe eosinophilic asthma patients at baseline and after benralizumab initiation and treatment duration with benralizumab

  Medication history: asthma treatment type, doses and treatment duration Proportion of patients with biologic discontinued and reason for discontinuation Benralizumab treatment patterns: benralizumab treatment duration, frequency of benralizumab treatment discontinuation, time to treatment discontinuation and frequency and type of concurrent respiratory medication

  Baseline, 3, 6, 12 and 24 months

Secondary Outcomes (2)

• Clinical outcomes after initiation of benralizumab theraoy in severe eosinophilic asthma patients

  Baseline, 3, 6, 12 and 24 months

• Asthma-related Healthcare resource utilization (HCRU) among severe eosinophilic asthma patients before and after initiation of benralizumab therapy

  Baseline, 3, 6, 12 and 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Severe eosinophilic asthma patients aged 18 and above, treated with benralizumab and who have had their first benralizumab dose between July 2019 and October 2020 and who have at least 1 benralizumab injection and with at least 3 months follow-up data from the first injection.

You may qualify if:

• 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 follow-up data from the first injection.
• Give voluntary signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (16)

Hospital Prof. Dr. Fernando Fonseca

Amadora, 2720-276, Portugal

Location

HSMM

Barcelos, 4750-275, Portugal

Location

CHUC - Imunoalergologia

Coimbra, 3000 -076, Portugal

Location

CHUC - Pneumologia

Coimbra, 3000 -076, Portugal

Location

CHUA

Faro, 8000-368, Portugal

Location

Hospital Leiria

Leiria, 2410-197, Portugal

Location

Chln - Hsm

Lisbon, 1649-035, Portugal

Location

Chuln - Hsm

Lisbon, 1649-035, Portugal

Location

Hospital Pedro Hispano

Matosinhos Municipality, 4464-513, Portugal

Location

CHUA

Portimão, 8500-338, Portugal

Location

CHUSJ - Imuno

Porto, 4200 - 319, Portugal

Location

CHUSJ - Pneumo

Porto, 4200 - 319, Portugal

Location

Chusj - Cri

Porto, 4200-319, Portugal

Location

Hospital Distrital de Santarém

Santarém, 2005-177, Portugal

Location

CHVNGE

Vila Nova de Gaia, 4430 - 999, Portugal

Location

CHTMAD

Vila Real, 5000-508, Portugal

Location

Related Links

• D3250R00088\_CSR Synopsis\_Redacted

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rosa Fernandes

  Hospital Pedro Hispano

  PRINCIPAL INVESTIGATOR

• Claudia Loureiro

  CHUC Pneumo

  PRINCIPAL INVESTIGATOR

• Carlos Loureiro

  CHUC Imuno

  PRINCIPAL INVESTIGATOR

• Ulisses Brito

  CHUA - Faro

  PRINCIPAL INVESTIGATOR

• Inês Belchior

  CHUA - Portimão

  PRINCIPAL INVESTIGATOR

• Ana Mendes

  CHLN- HSM - Imuno

  PRINCIPAL INVESTIGATOR

• Gonçalo Portugal

  CHLN - HSM - Pneumo

  PRINCIPAL INVESTIGATOR

• Rita Boaventura

  Hospital S. João- Pneumo

  PRINCIPAL INVESTIGATOR

• José Plácido

  Hospital S. João - Imuno

  PRINCIPAL INVESTIGATOR

• Cecília Pardal

  Hospital Prof. Dr. Fernando Fonseca

  PRINCIPAL INVESTIGATOR

• Gustavo Reis

  Hospital Distrital de Santarém

  PRINCIPAL INVESTIGATOR

• Ricardo Lima

  CHVNGE

  PRINCIPAL INVESTIGATOR

• Liliana Ribeiro

  Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro

  PRINCIPAL INVESTIGATOR

• Nuno Pires

  HSMM- Barcelos

  PRINCIPAL INVESTIGATOR

• Nuno Sousa

  Hospital Leiria

  PRINCIPAL INVESTIGATOR

• Filipa Carriço

  Hospital São João - CRI

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: August 10, 2021
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (16)