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

NCT05652439 · tracked via the Priya Life Science UK tracker

Sponsor

Chiesi Farmaceutici S.p.A.

Phase

Observational

Started

2022-12-02

Last updated

2025-05-04

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

Observational retrospective data collection

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

Study 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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of Major Adverse Cardiovascular Events (MACE) — 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

Trial sites (1)

Facility	City	Region	Status
Clinical Practice Research Datalink (CPRD)	London	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05652439 on ClinicalTrials.gov ↗ ← All trials in the UK