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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 362

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100033
      • Site 156119 - Peking University People's Hospital
    • Beijing, Beijing Municipality, China, 102300
      • Site 156110 Beijing Jingmei Group Genetal Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Site 156101 - The First Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510260
      • Site 156113 - The Second Affiliated Hospital of Guangzhou Medical University
    • Zhanjiang, Guangdong, China, 524003
      • Site 156114 - The Second Affiliated Hospital of Guangdong Medical University
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Site 156108 - Henan Provincial People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Site 156125 - Nanjing Drum Tower Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • Site 156117 - The Second Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jinan, Shandong, China, 250021
      • Site 156109 - Shandong Provincial Hospital
  • Sichuan
    • Deyang, Sichuan, China, 618000
      • Site 156122 - Deyang People's Hospital
    • Mianyang, Sichuan, China, 450003
      • Site 156102 - Mianyang Central Hospital
  • Xinjiang Uygur
    • Ürümqi, Xinjiang Uygur, China, 830054
      • Site 156121 - The First Affiliated Hospital of Xinjiang Medical University
  • Zhejiang
    • Huzhou, Zhejiang, China, 313000
      • Site 156106 - Huzhou Central Hospital
    • Jinhua, Zhejiang, China, 321083
      • Site 156115 - Jinhua Central Hospital
    • Lishui, Zhejiang, China, 323088
      • Site 156124 - Lishui People's Hospital
    • Ningbo, Zhejiang, China, 315010
      • Site 156112 - The First Affiliated Hospital of Ningbo University
    • Shaoxing, Zhejiang, China, 312000
      • Site 156103 - Shaoxing People's Hospital
    • Taizhou, Zhejiang, China, 318000
      • Site 156105 - Taizhou Central Hospital
    • Wenling, Zhejiang, China, 317599
      • Site 156123 - Wenling People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Subjects who are willing and able to give their written consent to participate in the study
2. Aged ≥40 years at BDP/FF/GB initiation
3. Had documented diagnosis of COPD prior to BDP/FF/GB initiation
4. 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)
5. 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

Exclusion Criteria:

1. Subjects who had been admitted to hospital for a COPD exacerbation within the last 4 weeks prior to BDP/FF/GB initiation
2. Subjects who are not likely to come back 12-weeks after BDP/FF/GB initiation, per Investigator judgement
3. Participation in any clinical trial in the 4 weeks prior to BDP/FF/GB initiation
4. Subjects had used any other single inhaler triple therapy before or at BDP/FF/GB initiation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness Measure	COPD Assessment Test total score	After 12-weeks of treatment with BDP/FF/GB on disease status

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Jinping Zheng, MD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Actual): September 12, 2025
• Study Completion (Actual): September 12, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Lung functions
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CLI-05993AA1-23; CTR20241876 (Registry Identifier: Center for Drug Evaluation (China))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No