PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI) (TRIBE)

April 30, 2025 updated by: Chiesi Farmaceutici S.p.A.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Observational retrospective data collection
Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes
Other Names:
  • No treatment given
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
Other: Observational retrospective data collection
Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes
Other Names:
  • No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of major cardiovascular and cerebrovascular events individually
Time Frame: Through study completion, up to 5 years

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
Through study completion, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Fabian Hoti, IQVIA Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLI-05993BA1-05
  • EUPAS47420 (Other Identifier: EU PAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only aggregated data will be analysed in this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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