Clinical trial NCT06605885: An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
Official title: An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-09-20
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 200 asthma patients will be enrolled in this study distributed among 50 sites in China.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the proportion of days covered (PDC) with asthma biologics during 52 weeks
timeFrame: week52
Secondary outcomes:
measure: Time from asthma onset to first biologic initiation(month)
timeFrame: week0
measure: Duration (days) of treatment with different type of biologics.
timeFrame: week 52
measure: Proportion of patients discontinued biologics in week 24 and week 52.
timeFrame: week24,week52
measure: Proportion of participants switching to other biologics for asthma in week 24 and week 52.
timeFrame: week24,week52
measure: Proportion of participants with concurrent used of multiple biologics in week 24 and week 52.
timeFrame: week24,week52
measure: Proportion of different categories including anti-IL5, anti-IL5R, anti-IL4R, anti-IgE and anti-TSLP of biologics during 52 weeks
timeFrame: week 52
measure: Proportion of patients experiencing asthma related hospitalizations during 52 weeks
timeFrame: week 52
measure: Cost of asthma related hospitalization during 52 weeks
timeFrame: week 52
measure: Days on asthma related sick leaves during 52 weeks
timeFrame: week 52
measure: Number of emergency visit during 52 weeks
timeFrame: week 52
measure: Annualized exacerbation rates over 52 weeks
timeFrame: week 52
measure: Change from baseline of FEV1 at week 24, 52
timeFrame: week0,week 24, week 52
measure: Change from baseline of ACT score at week 24, 52
timeFrame: week0,week 24,week52
measure: Change from baseline of AQLQ(S)+12 score at week 24, 52
timeFrame: week0,week24,week52
measure: Change of proportion of patients with high-dosage ICS from baseline to week 24,52
timeFrame: week0,week24,week52
measure: Change of proportion of patients with maintenance OCS from baseline to week 24,52
timeFrame: week0,week 24,Week 52
measure: Proportion of days covered (PDC) with maintenance medication at baseline (in last 3 months)
timeFrame: week0
measure: Levels of bEOS at baseline
timeFrame: week0
measure: Levels of FeNO at baseline
timeFrame: week0
measure: Levels of IgE at baseline
timeFrame: week0
Other outcomes:
measure: Proportion of different reasons for biologics discontinuation
timeFrame: week52
measure: Proportion of different reasons for biologics switching
timeFrame: week52
measure: Incidence of all AEs and SAEs
timeFrame: week52
Locations:
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Foshan
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Huhhot
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Ningbo
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Quanzhou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Suining
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Urumqi
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuxi
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Zhuhai
country: China
facility: Research Site
Study officials:
affiliation: The Fifth Affiliated Hospital, Sun Yat-sen University
name: YuBiao Guo
role: PRINCIPAL_INVESTIGATOR
References: