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

Recruitingn/aAges 40 Years - anyAllChiesi Farmaceutici S.p.A.
NCT05652439 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Observational retrospective data collection
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Where

1 site
Clinical Practice Research Datalink (CPRD)
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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