Severe AsthmaBetreatNCT07159295
Study in Portuguese Hospitals to Describe Patient Characteristics, Treatment Patterns and Outcomes
An observational study of Severe Asthma, run by AstraZeneca at 16 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- How many people
- 74 participants
- Where
- 16 sitesPortugal
- Study dates
- 10 Aug 2021to 3 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Currently receiving benralizumab or any other biologic drug for the treatment of asthma in a clinical trial
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Portugal16 sites
Hospital Prof. Dr. Fernando Fonseca
Amadora, 2720-276
HSMM
Barcelos, 4750-275
CHUC - Imunoalergologia
Coimbra, 3000 -076
CHUC - Pneumologia
Coimbra, 3000 -076
CHUA
Faro, 8000-368
Hospital Leiria
Leiria, 2410-197
Chln - Hsm
Lisbon, 1649-035
Chuln - Hsm
Lisbon, 1649-035
Hospital Pedro Hispano
Matosinhos Municipality, 4464-513
CHUA
Portimão, 8500-338
CHUSJ - Imuno
Porto, 4200 - 319
CHUSJ - Pneumo
Porto, 4200 - 319
Chusj - Cri
Porto, 4200-319
Hospital Distrital de Santarém
Santarém, 2005-177
CHVNGE
Vila Nova de Gaia, 4430 - 999
CHTMAD
Vila Real, 5000-508
About this study
Official title: Betreat (Xaloc1) Benralizumab Study: Retrospective, Observational 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.
Read the 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
- Severe Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, 3, 6, 12 and 24 months
Secondary outcomes (2)
Clinical outcomes after initiation of benralizumab theraoy in severe eosinophilic asthma patients
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%
Measured: 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
Number of emergency room visits, Number of schedule medical visits for asthma, Number of unscheduled medical visits for asthma, Number of hospitalizations
Measured: Baseline, 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start10 Aug 2021
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosa Fernandes, Principal investigator, Hospital Pedro HispanoClaudia Loureiro, Principal investigator, CHUC PneumoCarlos Loureiro, Principal investigator, CHUC ImunoUlisses Brito, Principal investigator, CHUA - FaroInês Belchior, Principal investigator, CHUA - PortimãoAna Mendes, Principal investigator, CHLN- HSM - ImunoGonçalo Portugal, Principal investigator, CHLN - HSM - PneumoRita Boaventura, Principal investigator, Hospital S. João- Pneumo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159295
- Sponsor's protocol ID
- D3250R00088
- Acronym
- Betreat
- Status last verified
- Oct 2025
- First submitted
- 29 Aug 2025
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No IPD is planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betreat (Xaloc1) Benralizumab Study: Retrospective, Observational Study in Portuguese Hospitals to Describe Patient Characteristics, Treatment Patterns and Outcomes
- ClinicalTrials.gov ID
- NCT07159295
- Acronym / sponsor ID
- Betreat / D3250R00088
- Conditions
- Severe Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults patients with severe asthma treated with benralizumab, who had their first benralizumab dose between July 2019 and October 2020
Key exclusion criteria (1 listed)
- Currently receiving benralizumab or any other biologic drug for the treatment of asthma in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
2 secondary outcomes
Clinical outcomes after initiation of benralizumab theraoy in severe eosinophilic asthma patients
Time frame: 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
Time frame: Baseline, 3, 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- D3250R00088\_CSR Synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: No. No IPD is planned to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Fernandes principal investigator
Hospital Pedro Hispano
Claudia Loureiro principal investigator
CHUC Pneumo
Carlos Loureiro principal investigator
CHUC Imuno
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by AstraZeneca at 16 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline demographic and clinical characteristics of severe eosinophilic asthma patients treated with benralizumab (time frame: Baseline/Index date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.