An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 202
- Locations
- 30
- Primary Endpoint
- the proportion of days covered (PDC) with asthma biologics during 52 weeks
Study Overview
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.
Detailed Description
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
the proportion of days covered (PDC) with asthma biologics during 52 weeks
Time Frame: week52
to describe the persistence to asthma biologics using proportion of days covered (PDC) with asthma biologics during 52 weeks.
Secondary Outcomes
- Proportion of participants switching to other biologics for asthma in week 24 and week 52.(week24,week52)
- 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 with concurrent used of multiple biologics in week 24 and week 52.(week24,week52)
- Proportion of different categories including anti-IL5, anti-IL5R, anti-IL4R, anti-IgE and anti-TSLP of biologics during 52 weeks(week 52)
- Proportion of patients experiencing asthma related hospitalizations during 52 weeks(week 52)
- Cost of asthma related hospitalization during 52 weeks(week 52)
- Days on asthma related sick leaves during 52 weeks(week 52)
- Number of emergency visit during 52 weeks(week 52)
- Annualized exacerbation rates over 52 weeks(week 52)
- Change from baseline of FEV1 at week 24, 52(week0,week 24, week 52)
- Change from baseline of ACT score at week 24, 52(week0,week 24,week52)
- Change from baseline of AQLQ(S)+12 score at week 24, 52(week0,week24,week52)
- Change of proportion of patients with high-dosage ICS from baseline to week 24,52(week0,week24,week52)
- Change of proportion of patients with maintenance OCS from baseline to week 24,52(week0,week 24,Week 52)
- Proportion of days covered (PDC) with maintenance medication at baseline (in last 3 months)(week0)
- Levels of bEOS at baseline(week0)
- Levels of FeNO at baseline(week0)
- Levels of IgE at baseline(week0)