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

Chronic Obstructive Pulmonary Disease Clinical Trial

— TRIBE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652439
• Other study ID #: CLI-05993BA1-05
• Secondary ID: EUPAS47420
• Status: Recruiting
• Start date: December 2, 2022
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Chiesi Farmaceutici S.p.A.
• Contact: Clinical Trial Info
• Phone: +3905212791
• Email: clinicaltrials_info[@]chiesi.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 fixed 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
• Hospitalization due to cardiovascular causes in the previous 30 days before the index date.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Observational retrospective data collection
Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes

Locations

Country	Name	City	State
United Kingdom	Clinical Practice Research Datalink (CPRD)	London

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, up to 5 years
Secondary	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	Through study completion, up to 5 years