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Recruiting NCT05652439

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

— Observational Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational retrospective data collection.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

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.

Interventions

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

Primary outcome measures

  • Incidence of Major Adverse Cardiovascular Events (MACE) [Time frame: Through study completion, up to 5 years]
Secondary outcome measures (1)
  • Incidence of major cardiovascular and cerebrovascular events individually [Time frame: Through study completion, up to 5 years]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Clinical Practice Research Datalink (CPRD) — London

Identifiers

NCT: NCT05652439 · CLI-05993BA1-05 · EUPAS47420

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗