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

Phase

N/A

Condition

N/A

Treatment

Observational retrospective data collection

Clinical Study ID

NCT05652439

CLI-05993BA1-05

EUPAS47420

Ages > 40
All Genders

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 Criteria

Inclusion

Inclusion Criteria:

Patients diagnosed with COPD
40 years or older
Availability of baseline information for a minimum of 12 months before the indexdate
New users of single inhaler triple therapy BDP/FF/GB via DPI or pMDI

Exclusion

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 inhalertriple therapy in addition to a study drug on the index date.
Hospitalization due to cardiovascular causes in the previous 30 days before theindex date.

Study Design

Observational retrospective data collection

December 02, 2022

August 31, 2026

Study 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.

Connect with a study center

Clinical Practice Research Datalink (CPRD)
London,
United Kingdom
Active - Recruiting

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