Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605885
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
An Observational Prospective Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Observational Prospective Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESENTII
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 2Week 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 AQLQS12 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
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 2Week 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 AQLQS12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None