An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
NCT ID: NCT06605885
Last Updated: 2026-01-21
Study Results
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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ACTIVE_NOT_RECRUITING
202 participants
OBSERVATIONAL
2024-11-14
2026-09-30
Brief Summary
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Detailed Description
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Approximately 200 patients with a physician diagnosis of asthma and prescribed with asthma biologics at visit 1 will be enrolled in this study, distributed among 50 sites across different regions in China.
During the study period, patients will be identified consecutively and, if they meet eligibility criteria and provide informed consent will be entered into this observational study. Patients should have an asthma diagnosis and be prescribed at least once with biologics for asthma treatment at enrollment (Visit 1, Week 0).
After the enrollment, subjects will be followed up at Visit 2(Week 24) and Visit 3 (Week 52). V1, V2 and V3 will be followed up by on-site visit. At Visit 1, data within last 12 months will be retrospectively collected as baseline. Patients existing medical record (MR) data will be collected in week 24 and week 52. PROs (Asthma control test \[ACT\], Asthma Quality of Life Questionnaire (+12) \[AQLQ(S)+12\]) should be performed at Visit 1, Visit 2 and Visit 3.
No additional mandated interventions on top of routinely performed physician visits, examinations or treatments will be required. Patients will not receive any experimental disease management intervention or experimental treatment as a result of their participation in the study.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Age: no limitation
3. Physician-confirmed asthma diagnosis with documented evidence of diagnosis or evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests).
4. Participants or their legal guardians must be able to provide informed consent.
5. Prescription of asthma biologics at enrolment.
Exclusion Criteria
7. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study with the usage of biologics, or may influence the results of the study, or the patient's ability to participate in the study
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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YuBiao Guo
Role: PRINCIPAL_INVESTIGATOR
The Fifth Affiliated Hospital, Sun Yat-sen University
Locations
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Research Site
Hohhot, China, China
Research Site
Beijing, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Foshan, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hefei, , China
Research Site
Jinan, , China
Research Site
Kunming, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Ningbo, , China
Research Site
Qingdao, , China
Research Site
Quanzhou, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Shenzhen, , China
Research Site
Shijiazhuang, , China
Research Site
Suining, , China
Research Site
Taiyuan, , China
Research Site
Tianjin, , China
Research Site
Ürümqi, , China
Research Site
Wenzhou, , China
Research Site
Wuhan, , China
Research Site
Wuxi, , China
Research Site
Xi'an, , China
Research Site
Zhengzhou, , China
Research Site
Zhuhai, , China
Countries
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Other Identifiers
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D5180R00039
Identifier Type: -
Identifier Source: org_study_id
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