Evaluate the Safety Profile of BGF MDI in Chinese Patients With COPD in Routine Clinical Practice
TORES
A Multi-centre, Prospective, Observational Post-Authorization Safety Study to Evaluate the Safety Profile of Budesonide/Glycopyrrolate/Formoterol MDI in Chinese Patients With COPD in Routine Clinical Practice
1 other identifier
observational
3,520
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Typical duration for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedStudy Start
First participant enrolled
March 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2023
CompletedJuly 29, 2024
July 1, 2024
2.6 years
August 28, 2020
July 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of all AEs /SAEs
To evaluate the safety profile after BGF MDI treatment in Chinese COPD patients
2022-12-30
Secondary Outcomes (5)
Change from baseline in CAT score
2022-12-30
Change from baseline in SGRQ score
2022-12-30
ADT MDI preference questionnaire (AMPQ)
2022-12-30
Patient global impression of change (PGIC)
2022-12-30
Mean total COPD cost including the direct and indirect COPD cost
2022-12-30
Eligibility Criteria
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.
You may qualify if:
- Give their signed written informed consent to participate
- Age: 18 and above
- Chinese, Female or male
- Patient with diagnosis of COPD as defined by clinicians
- Subjects who have been prescribed and have planned to take at least one inhalation of Budesonide/Glycopyrrolate/Formoterol MDI based on physician's decision.
You may not qualify if:
- Subjects who meet any of the following criteria will not be able to enter the study：
- Subjects who are currently involved in any other interventional studies.
- Drug Allergy: Subjects who have a history of hypersensitivity to formoterol or any other β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
- Subjects who received investigational drug treatment within 30 days prior to Visit 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (40)
Research Site
Beijing, 100070, China
Research Site
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
Related Links
Biospecimen
no sample collect in this study.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongchang Sun
Peking Universicy Third Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2020
First Posted
September 2, 2020
Study Start
March 16, 2021
Primary Completion
November 8, 2023
Study Completion
November 8, 2023
Last Updated
July 29, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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.