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This study is an observational, multicenter, prospective, single arm study. The objective of this study is to evaluate the safety of Breztri® Aerosphere® in Chinese patients with COPD in real world clinical practice. The study will enrol approximately 3,050 subjects from about 42 sites around China and followed up for 12 weeks.
This study is an observational, multicenter, prospective, single arm study. 3,050 subjects who have been prescribed and have planned to take at least one inhalation of BGF MDI will be enrolled into the study
This is an observational study. BGF MDI treatment will be studied through non-interventional approach. It will be carried out under routine clinical practice and the start or end of BGF MDI and other concomitant treatment will be determined by subjects' treating physicians.
Eligible subjects will be consecutively enrolled in this study at the time they routinely visit their physician and consent to participate in the study. After enrolled successfully, baseline variables will be collected at V1. Subjects will be followed up every 4 weeks after baseline for a total duration of 12 weeks or until study discontinuation, whichever occurs first. V1 and V2 will be followed up by on-site visit and V3 and V4 will be followed up by telephone call visit. For subjects who remain on study drug throughout the study (i.e., complete 4 Visits), a follow up telephone call will be performed at 14 days after the last visit to collect safety information. For subjects who has an Early Discontinuation, 14 days follow up is needed for AE collecting after the discontinuation. For subjects who had been hospitalized during the first 4 weeks of follow-up due to one or more acute exacerbations of COPD, a follow up telephone call will be performed at 28 days after the last visit to collect safety information.
The subjects will be recruited from qualified hospitals. Safety and effectiveness data will be collected following enrollment in the study. Medical records, PROs (COPD Assessment Test [CAT], St. George's Respiratory Questionnaire [SGRQ], Aerosphere Delivery Technology Metered Dose Inhaler Preference Questionnaire [AMPQ], Patient Global Impression of Change [PGIC]) will be the data source in this study.
Primary endpoint will be the incidence of AEs and SAEs in purpose of monitoring the safety profile of BGF MDI.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all AEs /SAEs | To evaluate the safety profile after BGF MDI treatment in Chinese COPD patients | 2022-12-30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in CAT score | To observe patients' health status after BGF MDI treatment via patient reported outcomes (PROs) | 2022-12-30 |
| Change from baseline in SGRQ score | To observe patients' health status after BGF MDI treatment via patient reported outcomes (PROs) |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who meet any of the following criteria will not be able to enter the study:
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The study will enroll 3,050 Chinese COPD patients who have been prescribed and have planned to take at least one inhalation of BGF MDI. The decision to start with BGF MDI treatment is independent of this study.
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| Name | Affiliation | Role |
|---|---|---|
| Yongchang Sun | Peking Universicy Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | 100070 | China | |||
| Research Site |
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| Label | URL |
|---|---|
| Redacted CSR synopsis | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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 shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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no sample collect in this study.
| 2022-12-30 |
| ADT MDI preference questionnaire (AMPQ) | To describe patient preference for the Aerosphere Delivery Technology | 2022-12-30 |
| Patient global impression of change (PGIC) | To observe patients' health status after BGF MDI treatment via patient reported outcomes (PROs) | 2022-12-30 |
| Mean total COPD cost including the direct and indirect COPD cost | To assess total direct and indirect COPD cost | 2022-12-30 |
| Beijing |
| China |
| Research Site | Changzhi | 046000 | China |
| Research Site | Chengdu | 610016 | China |
| Research Site | Chengdu | China |
| Research Site | Chifeng | China |
| Research Site | Chongqing | China |
| Research Site | Guangyuan | China |
| Research Site | Guangzhou | 510120 | China |
| Research Site | Guangzhou | 510150 | China |
| Research Site | Guangzhou | 510620 | China |
| Research Site | Haikou | 570311 | China |
| Research Site | Haikou | China |
| Research Site | Haining | China |
| Research Site | Hangzhou | 310005 | China |
| Research Site | Hangzhou | China |
| Research Site | Huizhou | China |
| Research Site | Jiaxing | China |
| Research Site | Jinan | 250012 | China |
| Research Site | Jinhua | 321000 | China |
| Research Site | Jinzhong | 030600 | China |
| Research Site | Mianyang | 621000 | China |
| Research Site | Nanjing | 211100 | China |
| Research Site | Nanjing | 223800 | China |
| Research Site | Shanghai | 200433 | China |
| Research Site | Shenzhen | 518039 | China |
| Research Site | Shenzhen | 518055 | China |
| Research Site | Shenzhen | 518100 | China |
| Research Site | Taizhou | 317000 | China |
| Research Site | Taizhou | 318000 | China |
| Research Site | Weifang | 261041 | China |
| Research Site | Wuxi | 214002 | China |
| Research Site | Xi'an | 710000 | China |
| Research Site | Xi'an | 710100 | China |
| Research Site | Xinxiang | China |
| Research Site | Xinzheng | 451100 | China |
| Research Site | Yangquan | 045000 | China |
| Research Site | Yinchuan | China |
| Research Site | Zhengzhou | China |
| Research Site | Zibo | China |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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