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

NCT ID: NCT06480890

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

362 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-02

Study Completion Date

2025-09-12

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinping Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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Site 156119 - Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Site 156110 Beijing Jingmei Group Genetal Hospital

Beijing, Beijing Municipality, China

Site Status

Site 156101 - The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Site 156113 - The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Site 156114 - The Second Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Site Status

Site 156108 - Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

Site 156125 - Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status

Site 156117 - The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Site 156109 - Shandong Provincial Hospital

Jinan, Shandong, China

Site Status

Site 156122 - Deyang People's Hospital

Deyang, Sichuan, China

Site Status

Site 156102 - Mianyang Central Hospital

Mianyang, Sichuan, China

Site Status

Site 156121 - The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur, China

Site Status

Site 156106 - Huzhou Central Hospital

Huzhou, Zhejiang, China

Site Status

Site 156115 - Jinhua Central Hospital

Jinhua, Zhejiang, China

Site Status

Site 156124 - Lishui People's Hospital

Lishui, Zhejiang, China

Site Status

Site 156112 - The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Site Status

Site 156103 - Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Site Status

Site 156105 - Taizhou Central Hospital

Taizhou, Zhejiang, China

Site Status

Site 156123 - Wenling People's Hospital

Wenling, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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CTR20241876

Identifier Type: REGISTRY

Identifier Source: secondary_id

CLI-05993AA1-23

Identifier Type: -

Identifier Source: org_study_id

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