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

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06480890
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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).

Study Timeline

• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-06-28
• Study Start: 2024-07-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 359

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety Measure	After 12-weeks of treatment with BDP/FF/GB	The number and percentage of subjects with any special situations will be summarised.
Effectiveness Measure	After 12-weeks of treatment with BDP/FF/GB	Mean absolute change from baseline in specific laboratory parameter values (i.e. eosinophil count) after 12 weeks of treatment with BDP/FF/GB.

Trial Locations

Locations (21)

Site 156118 - Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Site 156119 - Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Site 156116 - Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Site 156110 Beijing Jingmei Group Genetal Hospital; 🇨🇳 Beijing, Beijing, China

Site 156120 - The Second People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China

Site 156101 - The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Site 156113 - The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Site 156114 - The Second Affiliated Hospital of Guangdong Medical University; 🇨🇳 Zhanjiang, Guangdong, China

Site 156108 - Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Site 156107 - Shengjing Hospital of China Medical University; 🇨🇳 Shengyang, Liaoning, China

Site 156109 - Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

Site 156117 - The Second Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China

Site 156104 - Chengdu Second People's Hospital; 🇨🇳 Chengdu, Sichuan, China

Site 156111 - Chengdu Third People's Hospital; 🇨🇳 Chengdu, Sichuan, China

Site 156102 - Mianyang Central Hospital; 🇨🇳 Mianyang, Sichuan, China

Site 156121 - The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Ürümqi, Xinjiang, China

Site 156106 - Huzhou Central Hospital; 🇨🇳 Huzhou, Zhejiang, China

Site 156115 - Jinhua Central Hospital; 🇨🇳 Jinhua, Zhejiang, China

Site 156112 - The First Affiliated Hospital of Ningbo University; 🇨🇳 Ningbo, Zhejiang, China

Site 156103 - Shaoxing People's Hospital; 🇨🇳 Shaoxing, Zhejiang, China

Site 156105 - Taizhou Central Hospital; 🇨🇳 Taizhou, Zhejiang, China