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

Chiesi Farmaceutici S.p.A.25,000 enrolled

Overview

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.

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

25,000

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Through study completion, up to 5 years

Secondary Outcomes

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