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

NCT04536402

CompletedN/A

Sponsor: AstraZeneca

Conditions: Chronic Obstructive Pulmonary Disease

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.
Locations (40)
  • Beijing, China
  • Beijing, China
  • Changzhi, China
  • Chengdu, China
  • Chengdu, China
  • Chifeng, China
  • Chongqing, China
  • Guangyuan, China
  • Guangzhou, China
  • Guangzhou, China
  • Guangzhou, China
  • Haikou, China
  • Haikou, China
  • Haining, China
  • Hangzhou, China
  • Hangzhou, China
  • Huizhou, China
  • Jiaxing, China
  • Jinan, China
  • Jinhua, China
  • Jinzhong, China
  • Mianyang, China
  • Nanjing, China
  • Nanjing, China
  • Shanghai, China
  • Shenzhen, China
  • Shenzhen, China
  • Shenzhen, China
  • Taizhou, China
  • Taizhou, China
  • + 10 more on CT.gov