PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
Recruiting · NCT05652439 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chiesi Farmaceutici S.p.A.
View the official record on ClinicalTrials.gov →Interventions studied
Observational retrospective data collection
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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Clinical Practice Research Datalink (CPRD) - London, United Kingdom