Severe Eosinophilic AsthmaSPEEDNCT06862206
A Multicentre, Single Arm, Non-interventional, Real-world Study to Assess Demographic Characteristics and Patient Reported Outcomes in Patients With Severe Eosinophilic Asthma Treated With Benralizumab in China
An observational study of Severe Eosinophilic Asthma, run by AstraZeneca at 36 sites in China.
Trial summary
The objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Severe Eosinophilic Asthma
- What is being tested?
- benralizumab
- How many people
- 700 participants
- Where
- 36 sitesChina
- Study dates
- 11 Jul 2025to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: severe eosinophilic asthma
Who may be able to join
- Patients are eligible for inclusion only if all of the following criteria are met:
- Aged ≥12 years at the time of signing the informed consent form.
- Patients with severe eosinophilic asthma prescribed with benralizumab at the discretion of the clinician.
- For the patients who had received benralizumab prior to enrolment, the interval between the Index date and the date of enrolment must <=4 weeks;
- ACQ-6 score within 7 days prior to index date is required.
- Patients must have a current prescription for benralizumab with planned initiation of therapy.
- Participating patients and/or their legally authorized representative must provide signed and dated written informed consent form prior to any study specific procedures.
Who cannot join
- Patients should not be enrolled if any of the following exclusion criteria are met:
- Patients currently participating in any other interventional clinical trial.
- Known history of allergy or reaction to any component of benralizumab.
- Malignancy of any kind.
- Pregnant, breast-feeding or intending to become pregnant during the study period
Trial locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
36 sites in 1 country
China36 sites, 36 recruiting
- Recruiting
Research Site
Anning
- Recruiting
Research Site
Beijing
- Recruiting
Research Site
Binzhou
- Recruiting
Research Site
Changzhou
- Recruiting
Research Site
Fenyang
- Recruiting
Research Site
Guangdong
- Recruiting
Research Site
Guangzhou
- Recruiting
Research Site
Hangzhou
- Recruiting
Research Site
Hefei
- Recruiting
Research Site
Huzhou
- Recruiting
Research Site
Jiaxing
- Recruiting
Research Site
Jinan
- Recruiting
Research Site
Jinhua
- Recruiting
Research Site
Jining
- Recruiting
Research Site
Jiyuan
- Recruiting
Research Site
Kunshan
- Recruiting
Research Site
Linyi
- Recruiting
Research Site
Mianyang
- Recruiting
Research Site
Nanbu
- Recruiting
Research Site
Nanchang
- Recruiting
Research Site
Nanjing
- Recruiting
Research Site
Ningbo
- Recruiting
Research Site
Shanghai
- Recruiting
Research Site
Shanxi
- Recruiting
Research Site
Shenzhen
- Recruiting
Research Site
Shijiazhuang
- Recruiting
Research Site
Suining
- Recruiting
Research Site
Taiyuan
- Recruiting
Research Site
Weifang
- Recruiting
Research Site
Wuhan
- Recruiting
Research Site
Wuxi
- Recruiting
Research Site
Xi'an
- Recruiting
Research Site
Xiamen
- Recruiting
Research Site
Zhangjiagang
- Recruiting
Research Site
Zhengzhou
- Recruiting
Research Site
Zhenjiang
About this study
The objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. The study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in China. This study will also describe the physician-reported reasons for discontinuation and switching of benralizumab therapy.
- Conditions
- Severe Eosinophilic Asthma
- Being tested
- benralizumab
- Keywords
- asthma
- Medical subject headings
- Pulmonary Eosinophilia, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benralizumabDrug
non-interventional
| Study group | Role | What they receive |
|---|---|---|
| benralizumab group | non-interventional Receives: Drug: benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma control questionnaire
Change from baseline in the six-item Asthma Control Questionnaire (ACQ-6) score at Week 4 after initiation of benralizumab. The ACQ-6 is a 6-item version of the Asthma Control Questionnaire. The ACQ-6 score is calculated as the mean of the 6 items and ranges from 0 to 6, with higher scores indicating worse asthma control. Change from baseline is calculated as the post-baseline ACQ-6 score at Week 4 minus the baseline ACQ-6 score.
Measured: Week 4
Secondary outcomes (10)
Rate of exacerbations
- Changes from baseline in annualized rate of exacerbations over 56 weeks after initiation of benralizumab.
Measured: Week 56
percentage of patients with benralizumab discontinuation
- Percentage of patients with benralizumab discontinuation at Week 24, 40 and 56 after initiation of benralizumab
Measured: Week 24,40,56
Changes in Lung function
Change from Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (pre-BD FEV1)
Measured: Weeks 8, 24 and 56 after initiation of benralizumab
Changes in Lung function
Change from Baseline in Forced Vital Capacity (FVC)
Measured: Weeks 8, 24 and 56 after initiation of benralizumab
Changes in Lung function
Change from Baseline in FEV1/FVC Ratio
Measured: Weeks 8, 24 and 56 after initiation of benralizumab
Changes in Lung function
Change from Baseline in Peak Expiratory Flow (PEF)
Measured: Weeks 8, 24 and 56 after initiation of benralizumab
Changes in Lung function
Change from Baseline in Post-bronchodilator FEV1/FVC Ratio
Measured: Weeks 8, 24 and 56 after initiation of benralizumab
Change from Baseline in Six-item Asthma Control Questionnaire (ACQ-6) Score
The ACQ-6 score ranges from 0 to 6, with higher scores indicating worse asthma control. Change from baseline is calculated as the post-baseline ACQ-6 score minus the baseline ACQ-6 score.
Measured: Weeks 1, 2, 8, 16, 24, 40 and 56 after initiation of benralizumab
Percentage of Patients by Asthma Control Status Based on ACQ-6 Score
The ACQ-6 score ranges from 0 to 6, with higher scores indicating worse asthma control. Patients are categorized as well controlled (ACQ-6 score ≤0.75), partially controlled (ACQ-6 score >0.75 and <1.5), or uncontrolled (ACQ-6 score ≥1.5).
Measured: Weeks 1, 2, 4, 8, 16, 24, 32, 40, 48 and 56 after initiation of benralizumab
Percentage of Patients With Clinically Meaningful Improvement in ACQ-6 Score
The ACQ-6 score ranges from 0 to 6, with higher scores indicating worse asthma control. Clinically meaningful improvement is defined as at least (≥) a 0.5-unit improvement in ACQ-6 score from baseline.
Measured: Weeks 1, 2, 4, 8, 16, 24, 40 and 56 after initiation of benralizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start11 Jul 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Eosinophilic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- chen wang, PhD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862206
- Sponsor's protocol ID
- D3250R00131
- Acronym
- SPEED
- Status last verified
- Nov 2026
- First submitted
- 3 Mar 2025
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Single Arm, Non-interventional, Real-world Study to Assess Demographic Characteristics and Patient Reported Outcomes in Patients With Severe Eosinophilic Asthma Treated With Benralizumab in China
- ClinicalTrials.gov ID
- NCT06862206
- Acronym / sponsor ID
- SPEED / D3250R00131
- Conditions
- Severe Eosinophilic Asthma
- Keywords
- asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 6 Mar 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.
The objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. The study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in China. This study will also describe the physician-reported reasons for discontinuation and switching of benralizumab therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| benralizumab group | – | Drug: benralizumabnon-interventional |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- severe eosinophilic asthma
Key inclusion criteria (7 listed)
- Aged ≥12 years at the time of signing the informed consent form.
- Patients with severe eosinophilic asthma prescribed with benralizumab at the discretion of the clinician.
- For the patients who had received benralizumab prior to enrolment, the interval between the Index date and the date of enrolment must <=4 weeks;
- ACQ-6 score within 7 days prior to index date is required.
- Patients must have a current prescription for benralizumab with planned initiation of therapy.
Key exclusion criteria (5 listed)
- Patients currently participating in any other interventional clinical trial.
- Known history of allergy or reaction to any component of benralizumab.
- Malignancy of any kind.
- Pregnant, breast-feeding or intending to become pregnant during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benralizumabnon-interventional | Drug | benralizumab group |
Primary outcome
asthma control questionnaire
Time frame: Week 4
Change from baseline in the six-item Asthma Control Questionnaire (ACQ-6) score at Week 4 after initiation of benralizumab. The ACQ-6 is a 6-item version of the Asthma Control Questionnaire. The ACQ-6 score is calculated as the mean of the 6 items and ranges from 0 to 6, with higher scores indicating worse asthma control. Change from baseline is calculated as the post-baseline ACQ-6 score at Week 4 minus the baseline ACQ-6 score.
10 secondary outcomes
Rate of exacerbations
Time frame: Week 56
percentage of patients with benralizumab discontinuation
Time frame: Week 24,40,56
Changes in Lung function
Time frame: Weeks 8, 24 and 56 after initiation of benralizumab
Changes in Lung function
Time frame: Weeks 8, 24 and 56 after initiation of benralizumab
Changes in Lung function
Time frame: Weeks 8, 24 and 56 after initiation of benralizumab
Changes in Lung function
Time frame: Weeks 8, 24 and 56 after initiation of benralizumab
Changes in Lung function
Time frame: Weeks 8, 24 and 56 after initiation of benralizumab
Change from Baseline in Six-item Asthma Control Questionnaire (ACQ-6) Score
Time frame: Weeks 1, 2, 8, 16, 24, 40 and 56 after initiation of benralizumab
Percentage of Patients by Asthma Control Status Based on ACQ-6 Score
Time frame: Weeks 1, 2, 4, 8, 16, 24, 32, 40, 48 and 56 after initiation of benralizumab
Percentage of Patients With Clinically Meaningful Improvement in ACQ-6 Score
Time frame: Weeks 1, 2, 4, 8, 16, 24, 40 and 56 after initiation of benralizumab
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Related trials for Severe Eosinophilic Asthma
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A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
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Active, not recruitingPhase 4
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
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Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
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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.
AstraZeneca Clinical Study Information Center contact
chen wang, PhD principal investigator
China-Japan Friendship Hospital
36 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 Eosinophilic Asthma, run by AstraZeneca at 36 sites in China.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
asthma control questionnaire (time frame: Week 4). 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 9 Nov 2026.