Evaluate the Safety Profile of BGF MDI in Chinese Patients With COPD in Routine Clinical Practice

Chronic Obstructive Pulmonary Disease Clinical Trial

— TORES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536402
• Other study ID #: D5980R00016
• Status: Completed
• Start date: March 16, 2021
• Est. completion date: November 8, 2023

Study information

• Verified date: November 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3345
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß2-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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Changzhi
China	Research Site	Chengdu
China	Research Site	Chengdu
China	Research Site	Chifeng
China	Research Site	Chongqing
China	Research Site	Guangyuan
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Haikou
China	Research Site	Haikou
China	Research Site	Haining
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Huizhou
China	Research Site	Jiaxing
China	Research Site	Jinan
China	Research Site	Jinhua
China	Research Site	Jinzhong
China	Research Site	Mianyang
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Shenzhen
China	Research Site	Shenzhen
China	Research Site	Shenzhen
China	Research Site	Taizhou
China	Research Site	Taizhou
China	Research Site	Weifang
China	Research Site	Wuxi
China	Research Site	Xian
China	Research Site	Xian
China	Research Site	Xinxiang
China	Research Site	Xinzheng
China	Research Site	Yangquan
China	Research Site	Yinchuan
China	Research Site	Zhengzhou
China	Research Site	Zibo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all AEs /SAEs	To evaluate the safety profile after BGF MDI treatment in Chinese COPD patients	2022-12-30
Secondary	Change from baseline in CAT score	To observe patients' health status after BGF MDI treatment via patient reported outcomes (PROs)	2022-12-30
Secondary	Change from baseline in SGRQ score	To observe patients' health status after BGF MDI treatment via patient reported outcomes (PROs)	2022-12-30
Secondary	ADT MDI preference questionnaire (AMPQ)	To describe patient preference for the Aerosphere Delivery Technology	2022-12-30
Secondary	Patient global impression of change (PGIC)	To observe patients' health status after BGF MDI treatment via patient reported outcomes (PROs)	2022-12-30
Secondary	Mean total COPD cost including the direct and indirect COPD cost	To assess total direct and indirect COPD cost	2022-12-30