An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
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.
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.
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