NCT04536402Completed
Evaluate the Safety Profile of BGF MDI in Chinese Patients With COPD in Routine Clinical Practice
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
Source: ClinicalTrials.gov · Last updated 29 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3520 (actual)
- First submitted
- 28 Aug 2020
- Start date
- 16 Mar 2021
- Primary completion date
- 8 Nov 2023
- Lead sponsor
- AstraZeneca
- Diseases
- COPD
- NCT number
- NCT04536402
What you commit to
- Study type: Observational
- Participants enrolled: 3520
- From 16 Mar 2021 to the primary completion date, 8 Nov 2023
- 29 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who received investigational drug treatment within 30 days prior to Visit 1.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.