Asthma
Conditions
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Chinese, Female or Male 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
6. Participation in an interventional study within the last 3 months. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the proportion of days covered (PDC) with asthma biologics during 52 weeks | week52 | to describe the persistence to asthma biologics using proportion of days covered (PDC) with asthma biologics during 52 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from asthma onset to first biologic initiation(month) | week0 | To describe asthma biologics treatment features |
| Duration (days) of treatment with different type of biologics. | week 52 | To describe asthma biologics treatment features |
| Proportion of patients discontinued biologics in week 24 and week 52. | week24,week52 | To describe asthma biologics treatment features |
| Proportion of participants switching to other biologics for asthma in week 24 and week 52. | week24,week52 | To describe asthma biologics treatment features |
| Proportion of participants with concurrent used of multiple biologics in week 24 and week 52. | week24,week52 | To describe asthma biologics treatment features |
| Proportion of different categories including anti-IL5, anti-IL5R, anti-IL4R, anti-IgE and anti-TSLP of biologics during 52 weeks | week 52 | To describe asthma biologics treatment features |
| Proportion of patients experiencing asthma related hospitalizations during 52 weeks | week 52 | To describe effect of biologics on healthcare care resource utilization (HCRU) |
| Cost of asthma related hospitalization during 52 weeks | week 52 | To describe effect of biologics on healthcare care resource utilization (HCRU) |
| Days on asthma related sick leaves during 52 weeks | week 52 | To describe effect of biologics on healthcare care resource utilization (HCRU) |
| Number of emergency visit during 52 weeks | week 52 | To describe effect of biologics on healthcare care resource utilization (HCRU) |
| Annualized exacerbation rates over 52 weeks | week 52 | To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups |
| Change from baseline of FEV1 at week 24, 52 | week0,week 24, week 52 | To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups |
| Change from baseline of ACT score at week 24, 52 | week0,week 24,week52 | To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups |
| Change from baseline of AQLQ(S)+12 score at week 24, 52 | week0,week24,week52 | To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups |
| Change of proportion of patients with high-dosage ICS from baseline to week 24,52 | week0,week24,week52 | To describe maintenance treatment change after biologic initiation in two subgroups |
| Change of proportion of patients with maintenance OCS from baseline to week 24,52 | week0,week 24,Week 52 | To describe maintenance treatment change after biologic initiation in two subgroups |
| Proportion of days covered (PDC) with maintenance medication at baseline (in last 3 months) | week0 | To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups |
| Levels of bEOS at baseline | week0 | To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups |
| Levels of FeNO at baseline | week0 | To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups |
| Levels of IgE at baseline | week0 | To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYuBiao Guo
Fifth Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed