Skip to main content
OpenTrials
Completed

NCT Number: NCT07159295

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Prof. Dr. Fernando Fonseca, Amadora, Portugal

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline/Index date

    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

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

    Time frame: Baseline, 3, 6, 12 and 24 months

    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

Secondary outcomes

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

    Time frame: Baseline, 3, 6, 12 and 24 months

    Frequency of asthma exacerbations, annual rate of severe exacerbation, mean change in lung function (FEV1), FVC, reversibility of FEV1, blood eosinophil count, FeNO, Total IgE in peripheral blood, CARAT and ACT scores, proportion of patients achieving an improvement in CARAT ACT, percentage of patients with OCS ≤5mg/day, percentage change in daily OCS dose, percentage of patients experiencing reduction daily OCS use from index date by >0%, ≥25%, ≥50%, ≥75%, ≥90% and 100%

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

    Time frame: Baseline, 3, 6, 12 and 24 months

    Number of emergency room visits, Number of schedule medical visits for asthma, Number of unscheduled medical visits for asthma, Number of hospitalizations

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: Betreat

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 8, 2025
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.