Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)
TRIPHY
A 12-Week Single-Cohort Study, 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 COPD
2 other identifiers
observational
362
1 country
19
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2024
CompletedFirst Posted
Study publicly available on registry
June 28, 2024
CompletedStudy Start
First participant enrolled
July 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2025
CompletedDecember 12, 2025
December 1, 2025
1.2 years
June 12, 2024
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness Measure
COPD Assessment Test total score
After 12-weeks of treatment with BDP/FF/GB on disease status
Secondary Outcomes (6)
Effectiveness Measure
After 12-weeks of treatment with BDP/FF/GB
Effectiveness Measure
After 12-weeks of treatment with BDP/FF/GB
Effectiveness Measure
After 12-weeks of treatment with BDP/FF/GB
Safety Measure
After 12-weeks of treatment with BDP/FF/GB
Safety Measure
After 12-weeks of treatment with BDP/FF/GB
- +1 more secondary outcomes
Other Outcomes (1)
Treatment Adherence
After 12-weeks of treatment with BDP/FF/GB
Eligibility Criteria
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.
You may qualify if:
- Subjects who are willing and able to give their written consent to participate in the study
- Aged ≥40 years at BDP/FF/GB initiation
- Had documented diagnosis of COPD prior to BDP/FF/GB initiation
- Baseline CAT total score ≥10 (at the time of BDP/FF/GB initiation OR within the 12 weeks prior to treatment initiation, if no CAT total score is available on BDP/FF/GB initiation date)
- Subjects who have initiated treatment with BDP/FF/GB within 12 weeks prior to informed consent form (ICF) signature, or on date of ICF signature
You may not qualify if:
- Subjects who had been admitted to hospital for a COPD exacerbation within the last 4 weeks prior to BDP/FF/GB initiation
- Subjects who are not likely to come back 12-weeks after BDP/FF/GB initiation, per Investigator judgement
- Participation in any clinical trial in the 4 weeks prior to BDP/FF/GB initiation
- Subjects had used any other single inhaler triple therapy before or at BDP/FF/GB initiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Site 156119 - Peking University People's Hospital
Beijing, Beijing Municipality, 100033, China
Site 156110 Beijing Jingmei Group Genetal Hospital
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinping Zheng, MD
The First Affiliated Hospital of Guangzhou Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2024
First Posted
June 28, 2024
Study Start
July 2, 2024
Primary Completion
September 12, 2025
Study Completion
September 12, 2025
Last Updated
December 12, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share