NCT05652439Recruiting
PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 25000 (estimated)
- First submitted
- 2 Dec 2022
- Start date
- 2 Dec 2022
- Primary completion date
- Mar 2027
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Diseases
- COPD
- NCT number
- NCT05652439
What you commit to
- Study type: Observational
- Planned participants: 25000
- From 2 Dec 2022 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Practice Research Datalink (CPRD) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.