ClinicaliQ Trial Snapshot
- PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI) — Recruiting • Cardiology / Cardiovascular • NCT05652439.
- What is being tested: This Post Authorisation Safety Study (PASS) evaluates the incidence of cardiovascular and cerebrovascular adverse events in COPD patients newly initiating fixed triple therapy (dual bronchodilator plus inhaled corticosteroid) via dry powder inhaler or pressurised metered-dose inhaler.
- Patient eligibility overview: The trial includes COPD patients who are treatment-non-phase-specificïve to fixed triple therapy formulations and require initiation of this combination therapy, with monitoring for safety outcomes during treatment.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.