Chronic Obstructive Pulmonary DiseaseTRIBENCT05652439
PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
An observational study of Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
The aim of this Post Authorisation Safety Study (PASS) is to assess the incidence of adverse cardiovascular and cerebrovascular events in COPD patients who are new to inhaled fixed triple therapy (dual bronchodilator plus corticosteroid) administered via Dry Powder Inhaler (DPI) compared to new users of pressurized… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Observational retrospective data collection
- How many people
- 25,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Dec 2022to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will include patients diagnosed with COPD, aged 40 years or older. Eligible for inclusion will be patients with new use of single inhaler triple therapy BDP/FF/GB via DPI or pMDI and no use of any single or multi-inhaler triple therapy (including the study drugs) in the previous 90 days. The source population includes patients who have at least one prescription/dispensation of BDP/FF/GB administered via DPI or pMDI during the study period.
Who may be able to join
- Patients diagnosed with COPD
- 40 years or older
- Availability of baseline information for a minimum of 12 months before the index date
- New users of single inhaler triple therapy BDP/FF/GB via DPI or pMDI
Who cannot join
- Single or multi-inhaler triple therapy in the previous 90 days before the index date
- Prescription of BDP/FF/GP administered via pMDI or DPI or any other single inhaler triple therapy in addition to a study drug on the index date.
- Hospitalization due to cardiovascular causes in the previous 30 days before the index date.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Practice Research Datalink (CPRD)
London
Enquiries CPRD, enquiries@cprd.com
About this study
Official title: Multinational Database Cohort Study to Assess Adverse Cardiovascular and Cerebrovascular Outcomes in Patients With COPD Initiating a Fixed Triple Therapy Containing BDP, FF and GB Administered Via DPI Compared to pMDI
The aim of this Post Authorisation Safety Study (PASS) is to assess the incidence of adverse cardiovascular and cerebrovascular events in COPD patients who are new to inhaled fixed triple therapy (dual bronchodilator plus corticosteroid) administered via Dry Powder Inhaler (DPI) compared to new users of pressurized Metered Dose Inhaler (pMDI).
Data from clinical practice from different European data sources will be collected. The baseline hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.
Read the detailed description
Non-interventional, multi-country cohort study to assess the incidence of adverse cardiovascular and cerebrovascular events among patients with chronic obstructive pulmonary disease (COPD), exposed to inhaled fixed triple therapy BDP/FF/GB via DPI (drug of interest) or pMDI (comparator).
The study will be conducted based on secondary health data collected (as per clinical practice) retrospectively from seven different European data sources in the following countries: United Kingdom, Germany, The Netherlands, Denmark, Sweden, Norway and Finland.
Patients in the two exposure groups of this Post Authorisation Safety Study (PASS) will be followed for the study outcomes from the start of the exposure until the first occurrence of end of treatment, switch to the other study drug, end of the study period, or censoring. The pre-defined hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Observational retrospective data collection
- Keywords
- retrospective, cardiovascular, cerebrovascular, triple therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational retrospective data collectionOther
Also called No treatment given
Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes
| Study group | Role | What they receive |
|---|---|---|
| Fixed triple therapy BDP/FF/GB via DPI | COPD patients new users of fixed triple therapy BDP/FF/GB administered via DPI formulation according to local clinical practice Receives: Other: Observational retrospective data collection | |
| Fixed triple therapy BDP/FF/GB via pMDI | COPD patients new users of fixed triple therapy BDP/FF/GB administered via pMDI formulation according to local clinical practice Receives: Other: Observational retrospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Cardiovascular Events (MACE)
To assess the incidence of MACEs and compare it between fixed triple therapy BDP/FF/GB via DPI and pMDI formulation. MACEs will be defined as any of the following events:
- Myocardial infarction
- Stroke (ischemic and haemorrhagic stroke)
- Hospitalization due to acute coronary syndrome
- Hospitalization due to heart failure
Measured: Through study completion, up to 5 years
Secondary outcomes (1)
Incidence of major cardiovascular and cerebrovascular events individually
To assess the incidence of each of the following events individually:
- Myocardial infarction
- Cerebrovascular disorders (ischemic and haemorrhagic stroke, transient ischemic attack)
- Hospitalization due to acute coronary syndrome
- Hospitalization due to heart failure
- Arrhythmias (new-sustained supra-ventricular and sustained ventricular)
- All-cause death
Measured: Through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start2 Dec 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
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
- Retrospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabian Hoti, Principal investigator, IQVIA Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652439
- Sponsor's protocol ID
- CLI-05993BA1-05
- Other IDs
- EUPAS47420
- Acronym
- TRIBE
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated data will be analysed in this study
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multinational Database Cohort Study to Assess Adverse Cardiovascular and Cerebrovascular Outcomes in Patients With COPD Initiating a Fixed Triple Therapy Containing BDP, FF and GB Administered Via DPI Compared to pMDI
- ClinicalTrials.gov ID
- NCT05652439
- Acronym / sponsor ID
- TRIBE / CLI-05993BA1-05
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- retrospective, cardiovascular, cerebrovascular, triple therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Dec 2022 (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 aim of this Post Authorisation Safety Study (PASS) is to assess the incidence of adverse cardiovascular and cerebrovascular events in COPD patients who are new to inhaled fixed triple therapy (dual bronchodilator plus corticosteroid) administered via Dry Powder Inhaler (DPI) compared to new users of pressurized Metered Dose Inhaler (pMDI).
Data from clinical practice from different European data sources will be collected. The baseline hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.
Detailed description
Non-interventional, multi-country cohort study to assess the incidence of adverse cardiovascular and cerebrovascular events among patients with chronic obstructive pulmonary disease (COPD), exposed to inhaled fixed triple therapy BDP/FF/GB via DPI (drug of interest) or pMDI (comparator).
The study will be conducted based on secondary health data collected (as per clinical practice) retrospectively from seven different European data sources in the following countries: United Kingdom, Germany, The Netherlands, Denmark, Sweden, Norway and Finland.
Patients in the two exposure groups of this Post Authorisation Safety Study (PASS) will be followed for the study outcomes from the start of the exposure until the first occurrence of end of treatment, switch to the other study drug, end of the study period, or censoring. The pre-defined hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed triple therapy BDP/FF/GB via DPI | – | Other: Observational retrospective data collectionCOPD patients new users of fixed triple therapy BDP/FF/GB administered via DPI formulation according to local clinical practice |
| Fixed triple therapy BDP/FF/GB via pMDI | – | Other: Observational retrospective data collectionCOPD patients new users of fixed triple therapy BDP/FF/GB administered via pMDI formulation according to local clinical practice |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients diagnosed with COPD, aged 40 years or older. Eligible for inclusion will be patients with new use of single inhaler triple therapy BDP/FF/GB via DPI or pMDI and no use of any single or multi-inhaler triple therapy (including the study drugs) in the previous 90 days. The source population includes patients who have at least one prescription/dispensation of BDP/FF/GB administered via DPI or pMDI during the study period.
Key inclusion criteria (4 listed)
- Patients diagnosed with COPD
- 40 years or older
- Availability of baseline information for a minimum of 12 months before the index date
- New users of single inhaler triple therapy BDP/FF/GB via DPI or pMDI
Key exclusion criteria (3 listed)
- Single or multi-inhaler triple therapy in the previous 90 days before the index date
- Prescription of BDP/FF/GP administered via pMDI or DPI or any other single inhaler triple therapy in addition to a study drug on the index date.
- Hospitalization due to cardiovascular causes in the previous 30 days before the index date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational retrospective data collectionAlso: No treatment givenObservational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes | Other | Fixed triple therapy BDP/FF/GB via DPI, Fixed triple therapy BDP/FF/GB via pMDI |
Primary outcome
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: Through study completion, up to 5 years
To assess the incidence of MACEs and compare it between fixed triple therapy BDP/FF/GB via DPI and pMDI formulation. MACEs will be defined as any of the following events: * Myocardial infarction * Stroke (ischemic and haemorrhagic stroke) * Hospitalization due to acute coronary syndrome * Hospitalization due to heart failure
1 secondary outcome
Incidence of major cardiovascular and cerebrovascular events individually
Time frame: Through study completion, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. Only aggregated data will be analysed in this study
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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.
Fabian Hoti principal investigator
IQVIA Pty Ltd
1 site 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 1 site in United Kingdom.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Info (+3905212791, clinicaltrials_info@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Cardiovascular Events (MACE) (time frame: Through study completion, up to 5 years). 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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.