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RecruitingNCT05652439

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

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

Sponsor

Chiesi Farmaceutici S.p.A.

Enrollment

25,000 participants

Start Date

Dec 2, 2022

Study Type

OBSERVATIONAL

Conditions

Chronic Obstructive Pulmonary Disease

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This observational study tracks cardiovascular and stroke outcomes in COPD patients who are newly starting a triple-inhaler therapy (combining three different medications in one inhaler) to understand the real-world safety of this treatment. **You may be eligible if...** - You have been diagnosed with COPD (chronic obstructive pulmonary disease) - You are 40 or older - You are newly starting a specific triple-inhaler therapy (BDP/FF/GB) - You have at least 12 months of medical records available **You may NOT be eligible if...** - You have used triple therapy in the past 90 days - You have a history of certain cardiovascular conditions that would confound the analysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERObservational retrospective data collection

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

Locations(1)

Clinical Practice Research Datalink (CPRD)

London, United Kingdom

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NCT05652439

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