Evaluate the Safety Profile of BGF MDI in Chinese Patients With COPD in Routine Clinical Practice (TORES)
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- STATUS
- Recruiting
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- End date
- Dec 30, 2022
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- participants needed
- 3050
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- sponsor
- AstraZeneca
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.
Details
| Condition | Chronic Obstructive Pulmonary Disease |
|---|---|
| Clinical Study Identifier | NCT04536402 |
| Sponsor | AstraZeneca |
| Last Modified on | 15 June 2022 |
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