Chronic Obstructive Pulmonary DiseaseTRIPHYNCT06480890
Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)
An observational study of Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 19 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 362 participants
- Where
- 19 sitesChina
- Study dates
- 2 Jul 2024to 12 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subjects who are willing and able to give their written consent to participate in the study
- Aged ≥40 years at BDP/FF/GB initiation
- Had documented diagnosis of COPD prior to BDP/FF/GB initiation
- 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)
- 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
Who cannot join
- Subjects who had been admitted to hospital for a COPD exacerbation within the last 4 weeks prior to BDP/FF/GB initiation
- Subjects who are not likely to come back 12-weeks after BDP/FF/GB initiation, per Investigator judgement
- Participation in any clinical trial in the 4 weeks prior to BDP/FF/GB initiation
- Subjects had used any other single inhaler triple therapy before or at BDP/FF/GB initiation
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Site 156119 - Peking University People's Hospital
Beijing, Beijing Municipality, 100033
Site 156110 Beijing Jingmei Group Genetal Hospital
Beijing, Beijing Municipality, 102300
Site 156122 - Deyang People's Hospital
Deyang, Sichuan, 618000
Site 156101 - The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Site 156113 - The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Site 156106 - Huzhou Central Hospital
Huzhou, Zhejiang, 313000
Site 156109 - Shandong Provincial Hospital
Jinan, Shandong, 250021
Site 156115 - Jinhua Central Hospital
Jinhua, Zhejiang, 321083
Site 156124 - Lishui People's Hospital
Lishui, Zhejiang, 323088
Site 156102 - Mianyang Central Hospital
Mianyang, Sichuan, 450003
Site 156125 - Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Site 156112 - The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
Site 156103 - Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000
Site 156105 - Taizhou Central Hospital
Taizhou, Zhejiang, 318000
Site 156121 - The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur, 830054
Site 156123 - Wenling People's Hospital
Wenling, Zhejiang, 317599
Site 156117 - The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Site 156114 - The Second Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524003
Site 156108 - Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
About this study
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
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).
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Lung functions, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness Measure
COPD Assessment Test total score
Measured: After 12-weeks of treatment with BDP/FF/GB on disease status
Secondary outcomes (6)
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).
Measured: After 12-weeks of treatment with BDP/FF/GB
Effectiveness Measure
Mean absolute change from baseline in specific lung function parameter values (i.e. FEV1, FEV1 % of predicted, PEF) after 12 weeks of treatment with BDP/FF/GB.
Measured: After 12-weeks of treatment with BDP/FF/GB
Effectiveness Measure
Mean absolute change from baseline in specific laboratory parameter values (i.e. eosinophil count) after 12 weeks of treatment with BDP/FF/GB.
Measured: After 12-weeks of treatment with BDP/FF/GB
Safety Measure
Overall summary of AEs will be presented the number of subjects and percentage of subjects with any AEs.
Measured: After 12-weeks of treatment with BDP/FF/GB
Safety Measure
Overall summary of adverse drug reactions (ADRs) will be presented with the number of subjects and percentage of subjects with any ADRs.
Measured: After 12-weeks of treatment with BDP/FF/GB
Safety Measure
The number and percentage of subjects with any special situations will be summarised.
Measured: After 12-weeks of treatment with BDP/FF/GB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start2 Jul 2024
- Primary completion12 Sep 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinping Zheng, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480890
- Sponsor's protocol ID
- CLI-05993AA1-23
- Other IDs
- CTR20241876
- Acronym
- TRIPHY
- Status last verified
- Dec 2025
- First submitted
- 12 Jun 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06480890
- Acronym / sponsor ID
- TRIPHY / CLI-05993AA1-23
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Lung functions, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Subjects who are willing and able to give their written consent to participate in the study
- Aged ≥40 years at BDP/FF/GB initiation
- Had documented diagnosis of COPD prior to BDP/FF/GB initiation
- 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)
- 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
Key exclusion criteria (4 listed)
- Subjects who had been admitted to hospital for a COPD exacerbation within the last 4 weeks prior to BDP/FF/GB initiation
- Subjects who are not likely to come back 12-weeks after BDP/FF/GB initiation, per Investigator judgement
- Participation in any clinical trial in the 4 weeks prior to BDP/FF/GB initiation
- Subjects had used any other single inhaler triple therapy before or at BDP/FF/GB initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness Measure
Time frame: After 12-weeks of treatment with BDP/FF/GB on disease status
COPD Assessment Test total score
6 secondary outcomes
Effectiveness Measure
Time frame: After 12-weeks of treatment with BDP/FF/GB
Effectiveness Measure
Time frame: After 12-weeks of treatment with BDP/FF/GB
Effectiveness Measure
Time frame: After 12-weeks of treatment with BDP/FF/GB
Safety Measure
Time frame: After 12-weeks of treatment with BDP/FF/GB
Safety Measure
Time frame: After 12-weeks of treatment with BDP/FF/GB
Safety Measure
Time frame: After 12-weeks of treatment with BDP/FF/GB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinping Zheng, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness Measure (time frame: After 12-weeks of treatment with BDP/FF/GB on disease status). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.