Clinical trial NCT04536402: Evaluate the Safety Profile of BGF MDI in Chinese Patients With COPD in Routine Clinical Practice
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-09-02
Enrollment: 3520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of all AEs /SAEs
timeFrame: 2022-12-30
Secondary outcomes:
measure: Change from baseline in CAT score
timeFrame: 2022-12-30
measure: Change from baseline in SGRQ score
timeFrame: 2022-12-30
measure: ADT MDI preference questionnaire (AMPQ)
timeFrame: 2022-12-30
measure: Patient global impression of change (PGIC)
timeFrame: 2022-12-30
measure: Mean total COPD cost including the direct and indirect COPD cost
timeFrame: 2022-12-30
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changzhi
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chifeng
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Guangyuan
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Haikou
country: China
facility: Research Site
city: Haikou
country: China
facility: Research Site
city: Haining
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Huizhou
country: China
facility: Research Site
city: Jiaxing
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Jinhua
country: China
facility: Research Site
city: Jinzhong
country: China
facility: Research Site
city: Mianyang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Taizhou
country: China
facility: Research Site
city: Taizhou
country: China
facility: Research Site
city: Weifang
country: China
facility: Research Site
city: Wuxi
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
city: Xinxiang
country: China
facility: Research Site
city: Xinzheng
country: China
facility: Research Site
city: Yangquan
country: China
facility: Research Site
city: Yinchuan
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Zibo
country: China
facility: Research Site
Study officials:
affiliation: Peking Universicy Third Hospital
name: Yongchang Sun
role: PRINCIPAL_INVESTIGATOR
References: