Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT04808518
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed asthma diagnosis
2. Using high-dose ICSa and 2nd controllerb more than 3 months before registration
3. Uncontrolled asthma which constitutes one or more of 1) Poor symptom control: ACQ-5≧1.5 or ATC\<20 2) Frequent exacerbations: at least 2 asthma exacerbations in the 12 months prior to the registration 3) Airflow obstruction: FEV1 before taking bronchodilator \<80% predicted (FEV1/FVC less than the lower limit of normal) C
4. Investigators judges the necessity of biologic treatment for his/her asthma treatment and the patients are explained the situation by the investigators.
5. Patients deemed capable of visiting their study site next 24 months regularly
6. Patients from whom written consent to participate in this study has been obtained
7. Patients≧20 years old at obtaining consent
Exclusion Criteria:
1. Participated in other interventional studies such as clinical trials, etc within the last 8 weeks.
2. Are using biologics at registration
3. Diagnosed as COPD
4. Plan the BT therapy near future
5. Receipt of any marketed or investigational biologics within 5 months before the registration
6. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
* Affect the safety of the patient throughout the study
* Influence the findings of the studies or their interpretations
* Impede the patient's ability to complete the entire duration of study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04808518
Study Brief:
Protocol Section:
NCT04808518