Actively Recruiting
PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
Led by Chiesi Farmaceutici S.p.A. · Updated on 2025-05-04
25000
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Use of single or multi-inhaler triple therapy in the 90 days before the index date
- Prescription of BDP/FF/GP via pMDI or DPI or any other single inhaler triple therapy alongside a study drug on the index date
- Hospitalization due to cardiovascular causes in the 30 days before the index date
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Practice Research Datalink (CPRD)
London, United Kingdom
Actively Recruiting
Research Team
C
Clinical Trial Info
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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