PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
NCT ID: NCT05652439
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
25000 participants
OBSERVATIONAL
2022-12-02
2026-08-31
Brief Summary
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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.
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Detailed Description
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The study will be conducted based on secondary health data collected (as per clinical practice) retrospectively from seven different European data sources in the following countries: United Kingdom, Germany, The Netherlands, Denmark, Sweden, Norway and Finland.
Patients in the two exposure groups of this Post Authorisation Safety Study (PASS) will be followed for the study outcomes from the start of the exposure until the first occurrence of end of treatment, switch to the other study drug, end of the study period, or censoring. The pre-defined hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Fixed triple therapy BDP/FF/GB via DPI
COPD patients new users of fixed triple therapy BDP/FF/GB administered via DPI formulation according to local clinical practice
Observational retrospective data collection
Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes
Fixed triple therapy BDP/FF/GB via pMDI
COPD patients new users of fixed triple therapy BDP/FF/GB administered via pMDI formulation according to local clinical practice
Observational retrospective data collection
Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes
Interventions
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Observational retrospective data collection
Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Fabian Hoti
Role: PRINCIPAL_INVESTIGATOR
Iqvia Pty Ltd
Locations
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Clinical Practice Research Datalink (CPRD)
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EUPAS47420
Identifier Type: OTHER
Identifier Source: secondary_id
CLI-05993BA1-05
Identifier Type: -
Identifier Source: org_study_id
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