Condition: Chronic Obstructive Pulmonary Disease · Sponsor: Chiesi Farmaceutici S.p.A.
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.
This description comes directly from the study's public registry record.
Clinical Trial Info · +3905212791 · clinicaltrials_info@chiesi.com
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Source record: clinicaltrials.gov/study/NCT05652439