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

NCT ID: NCT07159295

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-10

Study Completion Date

2022-11-03

Brief Summary

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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.

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Detailed Description

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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

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Severe Asthma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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 follow-up 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosa Fernandes

Role: PRINCIPAL_INVESTIGATOR

Hospital Pedro Hispano

Claudia Loureiro

Role: PRINCIPAL_INVESTIGATOR

CHUC Pneumo

Carlos Loureiro

Role: PRINCIPAL_INVESTIGATOR

CHUC Imuno

Ulisses Brito

Role: PRINCIPAL_INVESTIGATOR

CHUA - Faro

Inês Belchior

Role: PRINCIPAL_INVESTIGATOR

CHUA - Portimão

Ana Mendes

Role: PRINCIPAL_INVESTIGATOR

CHLN- HSM - Imuno

Gonçalo Portugal

Role: PRINCIPAL_INVESTIGATOR

CHLN - HSM - Pneumo

Rita Boaventura

Role: PRINCIPAL_INVESTIGATOR

Hospital S. João- Pneumo

José Plácido

Role: PRINCIPAL_INVESTIGATOR

Hospital S. João - Imuno

Cecília Pardal

Role: PRINCIPAL_INVESTIGATOR

Hospital Prof. Dr. Fernando Fonseca

Gustavo Reis

Role: PRINCIPAL_INVESTIGATOR

Hospital Distrital de Santarém

Ricardo Lima

Role: PRINCIPAL_INVESTIGATOR

CHVNGE

Liliana Ribeiro

Role: PRINCIPAL_INVESTIGATOR

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

Nuno Pires

Role: PRINCIPAL_INVESTIGATOR

HSMM- Barcelos

Nuno Sousa

Role: PRINCIPAL_INVESTIGATOR

Hospital Leiria

Filipa Carriço

Role: PRINCIPAL_INVESTIGATOR

Hospital São João - CRI

Locations

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Hospital Prof. Dr. Fernando Fonseca

Amadora, , Portugal

Site Status

HSMM

Barcelos, , Portugal

Site Status

CHUC - Imunoalergologia

Coimbra, , Portugal

Site Status

CHUC - Pneumologia

Coimbra, , Portugal

Site Status

CHUA

Faro, , Portugal

Site Status

Hospital Leiria

Leiria, , Portugal

Site Status

Chln - Hsm

Lisbon, , Portugal

Site Status

Chuln - Hsm

Lisbon, , Portugal

Site Status

Hospital Pedro Hispano

Matosinhos Municipality, , Portugal

Site Status

CHUA

Portimão, , Portugal

Site Status

CHUSJ - Imuno

Porto, , Portugal

Site Status

CHUSJ - Pneumo

Porto, , Portugal

Site Status

Chusj - Cri

Porto, , Portugal

Site Status

Hospital Distrital de Santarém

Santarém, , Portugal

Site Status

CHVNGE

Vila Nova de Gaia, , Portugal

Site Status

CHTMAD

Vila Real, , Portugal

Site Status

Countries

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Portugal

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3250R00088&attachmentIdentifier=1aa77882-f9af-4dfc-92f4-f8cc413a6053&fileName=D3250R00088_CSR_Synopsis_Redacted.pdf&versionIdentifier=

D3250R00088\_CSR Synopsis\_Redacted

Other Identifiers

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D3250R00088

Identifier Type: -

Identifier Source: org_study_id

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