Clinical Trial

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

Study acronym: TRIBE
Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-12-14; most recent amendment 2025-04-30.
Status change: Not Yet Recruiting → Recruiting 2023-02-23
Trial Details
NCT Number NCT05652439
Lead Sponsor Chiesi Farmaceutici S.p.A.
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 25,000 participants
Start Date 2022-12-02
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-05-04