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Not Yet Recruiting NCT05652439

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

Conditions: Chronic Obstructive Pulmonary Disease

Sex: All
Ages: 40 Years – N/A
Enrollment: 25000
Sponsor: Chiesi Farmaceutici S.p.A.

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 Criteria:Patients diagnosed with COPD40 years or olderAvailability of baseline information for a minimum of 12 months before the index dateNew users of fixed triple therapy BDP/FF/GB via DPI or pMDIExclusion Criteria:Single or multi-inhaler triple therapy in the previous 90 days before the index dateHospitalization due to cardiovascular causes in the previous 30 days before the index date.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05652439). StuddyBuddy aggregates publicly available trial information.