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

Study Identifier:
CLI-05993BA1-05
ClinicalTrials.gov Identifier:
NCT05652439
EudraCT Identifier:
N/A
Study Contact Information:
+3905212791 or [email protected]
Recruiting

Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
    Date
    Dec 2022 - Aug 2026
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 40+ years
    Requirements Information
    Healthy Volunteers
    No

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Clinical Practice Research Datalink (CPRD)
    London, United Kingdom
    Status
    Recruiting