Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06480890

Acronym

TRIPHY

Enrollment

362

Registered

2024-06-28

Start date

2024-07-02

Completion date

2025-09-12

Last updated

2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Lung functions, COPD

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).

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Effectiveness Measure	After 12-weeks of treatment with BDP/FF/GB	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).
Safety Measure	After 12-weeks of treatment with BDP/FF/GB	Overall summary of AEs will be presented the number of subjects and percentage of subjects with any AEs.

Other

Measure	Time frame	Description
Treatment Adherence	After 12-weeks of treatment with BDP/FF/GB	Treatment adherence, by Test of Adherence to Inhaler (TAI)

Countries

China

Outcome results