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

NCT05652439 | Recruiting

• 2 other identifiers: CLI-05993BA1-05EUPAS47420
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

retrospective; cardiovascular; cerebrovascular; triple therapy

Outcome Measures

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

  Through study completion, up to 5 years

Secondary Outcomes (1)

• Incidence of major cardiovascular and cerebrovascular events individually

  Through study completion, up to 5 years

Study Arms (2)

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

Other: Observational retrospective data collection

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

Other: Observational retrospective data collection

Interventions

Observational retrospective data collection OTHER

Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes

Also known as: No treatment given

Fixed triple therapy BDP/FF/GB via DPI; Fixed triple therapy BDP/FF/GB via pMDI

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Patients diagnosed with COPD
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Clinical Practice Research Datalink (CPRD)

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabian Hoti

  Iqvia Pty Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Info

CONTACT

+3905212791; clinicaltrials_info@chiesi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 15, 2022
• Study Start: December 2, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)