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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will include patients diagnosed with COPD, aged 40 years or older. Eligible for inclusion will be patients with new use of single inhaler triple therapy BDP/FF/GB via DPI or pMDI and no use of any single or multi-inhaler triple therapy (including the study drugs) in the previous 90 days. The source population includes patients who have at least one prescription/dispensation of BDP/FF/GB administered via DPI or pMDI during the study period.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Observational retrospective data collection
Other interventionObservational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes
Treatment groups
25,000 Participants
are divided into 2 treatment groupsGroup A: Fixed triple therapy BDP/FF/GB via DPI1 intervention
Group B: Fixed triple therapy BDP/FF/GB via pMDI1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Major Adverse Cardiovascular Events (MACE)
To assess the incidence of MACEs and compare it between fixed triple therapy BDP/FF/GB via DPI and pMDI formulation. MACEs will be defined as any of the following events: * Myocardial infarction * Stroke (ischemic and haemorrhagic stroke) * Hospitalization due to acute coronary syndrome * Hospitalization due to heart failure
Time frame
Through study completion, up to 5 yearsSecondary outcomes
1
Incidence of major cardiovascular and cerebrovascular events individually
To assess the incidence of each of the following events individually: * Myocardial infarction * Cerebrovascular disorders (ischemic and haemorrhagic stroke, transient ischemic attack) * Hospitalization due to acute coronary syndrome * Hospitalization due to heart failure * Arrhythmias (new-sustained supra-ventricular and sustained ventricular) * All-cause death
Time frame
Through study completion, up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov