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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 3345

Contacts and Locations

• Study Contact: Name: Shuaishuai Ning; Phone Number: 8618911983343; Email: shuaishuai.ning@astrazeneca.com
• Study Contact Backup: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Beijing, China, 100070
    • Research Site
  • Beijing, China
    • Research Site
  • Changzhi, China, 046000
    • Research Site
  • Chengdu, China, 610016
    • Research Site
  • Chengdu, China
    • Research Site
  • Chifeng, China
    • Research Site
  • Chongqing, China
    • Research Site
  • Guangyuan, China
    • Research Site
  • Guangzhou, China, 510120
    • Research Site
  • Guangzhou, China, 510150
    • Research Site
  • Guangzhou, China, 510620
    • Research Site
  • Haikou, China, 570311
    • Research Site
  • Haikou, China
    • Research Site
  • Haining, China
    • Research Site
  • Hangzhou, China, 310005
    • Research Site
  • Hangzhou, China
    • Research Site
  • Huizhou, China
    • Research Site
  • Jiaxing, China
    • Research Site
  • Jinan, China, 250012
    • Research Site
  • Jinhua, China, 321000
    • Research Site
  • Jinzhong, China, 030600
    • Research Site
  • Mianyang, China, 621000
    • Research Site
  • Nanjing, China, 211100
    • Research Site
  • Nanjing, China, 223800
    • Research Site
  • Shanghai, China, 200433
    • Research Site
  • Shenzhen, China, 518039
    • Research Site
  • Shenzhen, China, 518055
    • Research Site
  • Shenzhen, China, 518100
    • Research Site
  • Taizhou, China, 317000
    • Research Site
  • Taizhou, China, 318000
    • Research Site
  • Weifang, China, 261041
    • Research Site
  • Wuxi, China, 214002
    • Research Site
  • Xian, China, 710000
    • Research Site
  • Xian, China, 710100
    • Research Site
  • Xinxiang, China
    • Research Site
  • Xinzheng, China, 451100
    • Research Site
  • Yangquan, China, 045000
    • Research Site
  • Yinchuan, China
    • Research Site
  • Zhengzhou, China
    • Research Site
  • Zibo, China
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Yongchang Sun, Peking Universicy Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D5980R00016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No