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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Observational retrospective data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fixed triple therapy BDP/FF/GB via DPI<br>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<br>* Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes<br>* Other names: No treatment given;|
| Fixed triple therapy BDP/FF/GB via pMDI<br>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<br>* Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes<br>* 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) | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retrospective, cardiovascular, cerebrovascular, triple therapy