Clinical trial NCT06480890: Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Lung functions
COPD
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2024-06-28
Enrollment: 359
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness Measure
timeFrame: After 12-weeks of treatment with BDP/FF/GB on disease status
Secondary outcomes:
measure: Effectiveness Measure
timeFrame: After 12-weeks of treatment with BDP/FF/GB
measure: Effectiveness Measure
timeFrame: After 12-weeks of treatment with BDP/FF/GB
measure: Effectiveness Measure
timeFrame: After 12-weeks of treatment with BDP/FF/GB
measure: Safety Measure
timeFrame: After 12-weeks of treatment with BDP/FF/GB
measure: Safety Measure
timeFrame: After 12-weeks of treatment with BDP/FF/GB
measure: Safety Measure
timeFrame: After 12-weeks of treatment with BDP/FF/GB
Other outcomes:
measure: Treatment Adherence
timeFrame: After 12-weeks of treatment with BDP/FF/GB
Locations:
city: Beijing
country: China
facility: Site 156118 - Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Site 156119 - Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Site 156116 - Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Site 156110 Beijing Jingmei Group Genetal Hospital
state: Beijing
city: Guangzhou
country: China
facility: Site 156101 - The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Site 156113 - The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Zhanjiang
country: China
facility: Site 156114 - The Second Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Site 156108 - Henan Provincial People's Hospital
state: Henan
city: Nanjing
country: China
facility: Site 156125 - Nanjing Drum Tower Hospital
state: Jiangsu
city: Xi'an
country: China
facility: Site 156117 - The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Site 156109 - Shandong Provincial Hospital
state: Shandong
city: Chengdu
country: China
facility: Site 156111 - Chengdu Third People's Hospital
state: Sichuan
city: Deyang
country: China
facility: Site 156122 - Deyang People's Hospital
state: Sichuan
city: Mianyang
country: China
facility: Site 156102 - Mianyang Central Hospital
state: Sichuan
city: Ürümqi
country: China
facility: Site 156121 - The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Huzhou
country: China
facility: Site 156106 - Huzhou Central Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Site 156115 - Jinhua Central Hospital
state: Zhejiang
city: Lishui
country: China
facility: Site 156124 - Lishui People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Site 156112 - The First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Shaoxing
country: China
facility: Site 156103 - Shaoxing People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Site 156105 - Taizhou Central Hospital
state: Zhejiang
city: Wenling
country: China
facility: Site 156123 - Wenling People's Hospital
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Jinping Zheng, MD
role: PRINCIPAL_INVESTIGATOR
References: