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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20241876 | Registry Identifier | Center for Drug Evaluation (China) |
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The purpose of the study is to evaluate Real-World Effectiveness of a Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Subjects with Chronic Obstructive Pulmonary Disease (COPD).
This real-world study is a multi-centre, single-cohort, ambi-directional observational cohort study with both retrospective and prospective data collection, with the primary objective to assess the 12-week effectiveness of BDP/FF/GB for COPD subjects in China. The index date is the initiation date of BDP/FF/GB, and subjects may have initiated treatment with BDP/FF/GB up to 12 weeks before enrolment. Baseline period is the 12 weeks prior to index date. The end of study (EOS) for each subject will be the earliest of the following: approximately 12 weeks after BDP/FF/GB initiation (the Week 12 Visit), BDP/FF/GB discontinuation plus 2 weeks, or at early withdrawal (such as consent withdrawal, death, or lost to follow-up).
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| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Measure | COPD Assessment Test total score | After 12-weeks of treatment with BDP/FF/GB on disease status |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Measure | Number and percentage of responders (i.e. subjects with a change from baseline in CAT total score ≤ -2) or non-responders (i.e. subjects with a change from baseline in CAT total score > -2 or with CAT total score at Week 12 missing). | After 12-weeks of treatment with BDP/FF/GB |
| Effectiveness Measure |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Adherence | Treatment adherence, by Test of Adherence to Inhaler (TAI) | After 12-weeks of treatment with BDP/FF/GB |
Inclusion Criteria:
Exclusion Criteria:
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Subjects with COPD (≥40 years and CAT total score ≥10) in China, who have newly initiated BDP/FF/GB without previous use of single inhaler triple therapy, and without recent hospitalisation for a COPD exacerbation. Detailed inclusion and exclusion criteria are listed below. Any treatment decision must have been taken prior to and independently of the subject's inclusion in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jinping Zheng, MD | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 156119 - Peking University People's Hospital | Beijing | Beijing Municipality | 100033 | China | ||
| Site 156110 Beijing Jingmei Group Genetal Hospital |
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Mean absolute change from baseline in specific lung function parameter values (i.e. FEV1, FEV1 % of predicted, PEF) after 12 weeks of treatment with BDP/FF/GB. |
| After 12-weeks of treatment with BDP/FF/GB |
| Effectiveness Measure | Mean absolute change from baseline in specific laboratory parameter values (i.e. eosinophil count) after 12 weeks of treatment with BDP/FF/GB. | After 12-weeks of treatment with BDP/FF/GB |
| Safety Measure | Overall summary of AEs will be presented the number of subjects and percentage of subjects with any AEs. | After 12-weeks of treatment with BDP/FF/GB |
| Safety Measure | Overall summary of adverse drug reactions (ADRs) will be presented with the number of subjects and percentage of subjects with any ADRs. | After 12-weeks of treatment with BDP/FF/GB |
| Safety Measure | The number and percentage of subjects with any special situations will be summarised. | After 12-weeks of treatment with BDP/FF/GB |
| Beijing |
| Beijing Municipality |
| 102300 |
| China |
| Site 156101 - The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| Site 156113 - The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510260 | China |
| Site 156114 - The Second Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | 524003 | China |
| Site 156108 - Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China |
| Site 156125 - Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| Site 156117 - The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710004 | China |
| Site 156109 - Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| Site 156122 - Deyang People's Hospital | Deyang | Sichuan | 618000 | China |
| Site 156102 - Mianyang Central Hospital | Mianyang | Sichuan | 450003 | China |
| Site 156121 - The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang Uygur | 830054 | China |
| Site 156106 - Huzhou Central Hospital | Huzhou | Zhejiang | 313000 | China |
| Site 156115 - Jinhua Central Hospital | Jinhua | Zhejiang | 321083 | China |
| Site 156124 - Lishui People's Hospital | Lishui | Zhejiang | 323088 | China |
| Site 156112 - The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | 315010 | China |
| Site 156103 - Shaoxing People's Hospital | Shaoxing | Zhejiang | 312000 | China |
| Site 156105 - Taizhou Central Hospital | Taizhou | Zhejiang | 318000 | China |
| Site 156123 - Wenling People's Hospital | Wenling | Zhejiang | 317599 | China |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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