RecruitingNot Applicable

PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)

United Kingdom25,000 participantsStarted 2022-12-02

Plain-language summary

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 participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of Major Adverse Cardiovascular Events (MACE)

Timeframe: Through study completion, up to 5 years

Trial details

NCT IDNCT05652439

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-08

Contact for this trial

Clinical Trial Info

+3905212791 clinicaltrials_info@chiesi.com

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials