PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorChiesi Farmaceutici S.p.A.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Observational retrospective data collection
Treatment groups
25,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov