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

Chiesi Farmaceutici S.p.A.362 enrolled

Overview

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).

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

362

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (19)

Site 156119 - Peking University People's Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Effectiveness Measure

COPD Assessment Test total score

Time frame: After 12-weeks of treatment with BDP/FF/GB on disease status

Secondary Outcomes

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).