Compares heart and brain blood vessel events in COPD patients on triple inhalers
Compares heart and stroke events in COPD patients starting one of two inhaler types.
Plain-language title generated from the registry record
Registry title: PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
Key facts
- Where
- London, United KingdomSee the site
Where in United Kingdom
- Clinical Practice Research Datalink (CPRD)London, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chiesi Farmaceutici S.p.A.
- Trial code
- NCT05652439
- Record updated
- 22 October 2026
- Original description
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).Read full original descriptionShow less
Multinational Database Cohort Study to Assess Adverse Cardiovascular and Cerebrovascular Outcomes in Patients With COPD Initiating a Fixed Triple Therapy Containing BDP, FF and GB Administered Via DPI Compared to pMDI
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.
Inclusion: 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.
Exclusion: Single or multi-inhaler triple therapy in the previous 90 days before the index date; Prescription of BDP/FF/GP administered via pMDI or DPI or any other single inhaler triple therapy in addition to a study drug on the index date; Hospitalization due to cardiovascular causes in the previous 30 days before the index date.