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This is a Prospective, Observational, Multicentre Study to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China. Sponsor by Astrazeneca Investment(China) Co., LTD.
This is a prospective, observational, multicentre study. Approximately 500 moderate-to-severe asthma patients from 30 sites across China. Patients will be treated following routine clinical practice. Study measures will be collected at week 0, week 12 and week 24.
The primary objective of PRESENT study is to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-to-Severe Asthma | enroll 500 subjects |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of uncontrolled patients with treatment modification, which is indicated by maintenance drug dosage change, switch, add-on, discontinue from week 0 to week 24 | To describe treatment modification of uncontrolled moderate-to-severe asthma patients in China. | week 0, week 12 and week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Ashma disease burden: Exacerbation rate | To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | To summarize the safety data, including frequency of adverse events | week 0, week 12 and week 24 |
| Percentage of adverse events. | To summarize the safety data, including percentage of adverse events. |
Inclusion Criteria:
Exclusion Criteria:
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Moderate-to-Severe Asthma Patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baoding | China | ||||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
URL: https://vivli.org/
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| week 0, week 12 and week 24 |
| Proportions of severe asthma (GINA 2023 & CN 2020 guideline) at baseline & each follow-up assessment | To describe the proportion of severe asthma among all patients according to GINA 2023 & CN 2020 guidelines | week 0, week 12 and week 24 |
| Levels of bEOS at each follow-up assessment. Proportions of eosinophilic phenotype | To describe EOS levels and proportion of eosinophilic phenotype patients at week 0,12&24 | week 0, week 12 and week 24 |
| Asthma-related emergency visit. | To describe healthcare utilization by baseline asthma severity (moderate or severe) | week 0, week 12 and week 24 |
| Ashma disease burden: Asthma Control Test | To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) | week 0, week 12 and week 24 |
| Ashma disease burden: Lung function (FEV1) | To describe disease burden of moderate-to-severe-asthma patients and to describe by different subgroups. To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) | week 0, week 12 and week 24 |
| Asthma disease burden: Treatment patterns | To describe disease burden and treatment patterns by stratification of baseline EOS and baseline eosinophilic phenotype at week 0,12&24. To describe disease burden and treatment patterns by baseline asthma severity(moderate or severe) at each follow-up assessment. To describe disease burden and treatment patterns by regions (south, west, east, north, central) | week 0, week 12 and week 24 |
| Asthma-related outpatient visit. | To describe healthcare utilization by baseline asthma severity (moderate or severe) | week 0, week 12 and week 24 |
| Asthma-related hospitalization: Length of stay, Invasive and non-invasive ventilator use. | To describe healthcare utilization by baseline asthma severity (moderate or severe) | week 0, week 12 and week 24 |
| Asthma-related diagnostic tests (X-ray, CT scan, et al.) | To describe healthcare utilization by baseline asthma severity (moderate or severe) | week 0, week 12 and week 24 |
| week 0, week 12 and week 24 |
| Frequency of serious adverse events. | To summarize the safety data, including frequency of serious adverse events. | week 0, week 12 and week 24. |
| Percentage of serious adverse events. | To summarize the safety data, including percentage of serious adverse events. | week 0, week 12 and week 24 |
| Beijing |
| China |
| Research Site | Changsha | China |
| Research Site | Chengdu | China |
| Research Site | Chongqing | China |
| Research Site | Dingzhou | China |
| Research Site | Hangzhou | China |
| Research Site | Harbin | China |
| Research Site | Hefei | China |
| Research Site | Hohhot | China |
| Research Site | Jinan | China |
| Research Site | Kunming | China |
| Research Site | Liuzhou | China |
| Research Site | Lu'an | China |
| Research Site | Luzhou | China |
| Research Site | Nanchang | China |
| Research Site | Nanchong | China |
| Research Site | Qingdao | China |
| Research Site | Quanzhou | China |
| Research Site | Shanghai | China |
| Research Site | Shenzhen | China |
| Research Site | Tianjin | China |
| Research Site | Tiaobingshan | China |
| Research Site | Wenzhou | China |
| Research Site | Wuhan | China |
| Research Site | Xi'an | China |
| Research Site | Xiamen | China |
| Research Site | Yongzhou | China |
| Research Site | Zhangjiagang | China |
| Research Site | Zhengzhou | China |
| Research Site | Zigong | China |