Real-world use of benralizumab in Chinese patients with severe eosinophilic asthma
A Multicentre, Single Arm, Non-interventional, Prospective Study to Assess Demographic Characteristics and Patient Reported Outcomes in Patients With Severe Eosinophilic Asthma Treated With Benralizumab in China
See how benralizumab works for people in China aged 12 and up with severe eosinophilic asthma when given as part of routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | benralizumab |
| Locations | 20 sites (Anhui and 19 other locations) |
| Trial ID | NCT06862206 on ClinicalTrials.gov |
What this trial studies
This is a non-interventional, observational study collecting demographic data and patient-reported outcomes from people in China who are prescribed benralizumab for severe eosinophilic asthma. The study will track early treatment response, changes in asthma control, and treatment outcomes over time in routine clinical practice. Investigators will also record physician-reported reasons for stopping or switching benralizumab and will enroll patients who meet specified blood eosinophil thresholds. Participation requires informed consent and excludes people already treated with benralizumab, those in other clinical trials, or those with malignancy or known allergy to study medication components.
Who should consider this trial
Good fit: Ideal candidates are people aged 12 or older in China with severe eosinophilic asthma who are being prescribed benralizumab for the first time and have recent blood eosinophil counts meeting the study thresholds.
Not a fit: Patients who have previously used benralizumab, have active malignancy, are enrolled in another clinical trial, or do not meet the required eosinophil criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could clarify which patients benefit most from benralizumab in real-world Chinese clinical practice and inform better treatment decisions.
How similar studies have performed: Randomized trials of benralizumab for severe eosinophilic asthma have shown clinical benefit, and real-world observational studies are increasingly supporting those findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria -Patients are eligible to be included in the study only if all of the following criteria apply: * Patients must to be 12 years old (inclusive) at the time of signing the informed consent. * Patients with severe eosinophilic asthma prescribed with benralizumab at the discretion of the clinician. * Blood EOS≥150/ul in the 3 months prior to or EOS≥300/ul in the 1 year prior to the time of signing the informed consent. * Participating patients and/or their legally authorized representative must provide signed and dated written informed consent form prior to any study specific procedures. Exclusion criteria -Patients should not enter the study if any of the following exclusion criteria are fulfilled: * Patients currently participating in any other clinical trial. * Known history of allergy or reaction to any component of the study treatment formulation. * Malignancy of any kind. * Patients with prior or ongoing treatment with benralizumab.
Where this trial is running
Anhui and 19 other locations
- Research Site — Anhui, China (Recruiting)
- Research Site — Beijing, China (Recruiting)
- Research Site — Binzhou, China (Recruiting)
- Research Site — Guangzhou, China (Recruiting)
- Research Site — Hangzhou, China (Recruiting)
- Research Site — Huzhou, China (Recruiting)
- Research Site — Jinan, China (Recruiting)
- Research Site — Jinhua, China (Recruiting)
- Research Site — Jining, China (Recruiting)
- Research Site — Linyi, China (Recruiting)
- Research Site — Mianyang, China (Recruiting)
- Research Site — Nanchang, China (Recruiting)
- Research Site — Nanjing, China (Recruiting)
- Research Site — Ningbo, China (Recruiting)
- Research Site — Shanghai, China (Recruiting)
- Research Site — Shanxi, China (Recruiting)
- Research Site — Suining, China (Recruiting)
- Research Site — Weifang, China (Recruiting)
- Research Site — Xi'an, China (Recruiting)
- Research Site — Zhengzhou, China (Recruiting)
Study contacts
- Principal investigator: chen wang, PhD — China-Japan Friendship Hospital
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.