Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
NCT03953300
Asthma, Bronchial Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT Number: NCT06605885
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 active but is not currently recruiting participants.
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Observational
Research Site, Hohhot, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: week52
to describe the persistence to asthma biologics using proportion of days covered (PDC) with asthma biologics during 52 weeks.
Time frame: week0
To describe asthma biologics treatment features
Time frame: week 52
To describe asthma biologics treatment features
Time frame: week24,week52
To describe asthma biologics treatment features
Time frame: week24,week52
To describe asthma biologics treatment features
Time frame: week24,week52
To describe asthma biologics treatment features
Time frame: week 52
To describe asthma biologics treatment features
Time frame: week 52
To describe effect of biologics on healthcare care resource utilization (HCRU)
Time frame: week 52
To describe effect of biologics on healthcare care resource utilization (HCRU)
Time frame: week 52
To describe effect of biologics on healthcare care resource utilization (HCRU)
Time frame: week 52
To describe effect of biologics on healthcare care resource utilization (HCRU)
Time frame: week 52
To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups
Time frame: week0,week 24, week 52
To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups
Time frame: week0,week 24,week52
To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups
Time frame: week0,week24,week52
To describe clinical outcomes of biologics including lung function, exacerbation, symptom control and quality of life in two subgroups
Time frame: week0,week24,week52
To describe maintenance treatment change after biologic initiation in two subgroups
Time frame: week0,week 24,Week 52
To describe maintenance treatment change after biologic initiation in two subgroups
Time frame: week0
To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups
Time frame: week0
To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups
Time frame: week0
To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups
Time frame: week0
To describe the characteristics including background therapy, biomarkers, asthma triggers and comorbidities of biologics treated asthma patients in two subgroups
Time frame: week52
To describe reasons for biologic discontinuation and switching, including asthma control, adverse event, cost or other more reasons.
Time frame: week52
To describe reasons for biologic discontinuation and switching, including asthma control, adverse event, cost or other more reasons.
Time frame: week52
To describe reasons for biologic discontinuation and switching, including asthma control, adverse event, cost or other more reasons.
AstraZeneca
Industry
Acronym: PRESENTII
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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