An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
PRESENTII
1 other identifier
observational
202
1 country
30
Brief Summary
This study is a multicenter, observational, prospective study to evaluate the asthma biologic use features and clinical outcomes in China. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2024
CompletedFirst Posted
Study publicly available on registry
September 20, 2024
CompletedStudy Start
First participant enrolled
November 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
May 6, 2026
May 1, 2026
1.9 years
September 12, 2024
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
the proportion of days covered (PDC) with asthma biologics during 52 weeks
to describe the persistence to asthma biologics using proportion of days covered (PDC) with asthma biologics during 52 weeks.
week52
Secondary Outcomes (20)
Time from asthma onset to first biologic initiation(month)
week0
Duration (days) of treatment with different type of biologics.
week 52
Proportion of patients discontinued biologics in week 24 and week 52.
week24,week52
Proportion of participants switching to other biologics for asthma in week 24 and week 52.
week24,week52
Proportion of participants with concurrent used of multiple biologics in week 24 and week 52.
week24,week52
- +15 more secondary outcomes
Other Outcomes (3)
Proportion of different reasons for biologics discontinuation
week52
Proportion of different reasons for biologics switching
week52
Incidence of all AEs and SAEs
week52
Eligibility Criteria
Approximately 200 asthma patients will be enrolled in this study distributed among 50 sites in China.
You may qualify if:
- Chinese, Female or Male
- Age: no limitation
- 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).
- Participants or their legal guardians must be able to provide informed consent.
- Prescription of asthma biologics at enrolment.
You may not qualify if:
- Participation in an interventional study within the last 3 months.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (30)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YuBiao Guo
The Fifth Affiliated Hospital, Sun Yat-sen University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2024
First Posted
September 20, 2024
Study Start
November 14, 2024
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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. 'Yes' , indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.