Multinational Database Cohort Study to Assess Adverse Cardiovascular and Cerebrovascular Outcomes in Patients With COPD Initiating a Fixed Triple Therapy Containing BDP, FF and GB Administered Via DPI Compared to pMDI

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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 fixed triple therapy BDP/FF/GB via DPI or pMDI

Locations
Other Locations
United Kingdom
Clinical Practice Research Datalink (CPRD)
RECRUITING
London
Contact Information
Primary
Clinical Trial Info
clinicaltrials_info@chiesi.com
+3905212791
Time Frame
Start Date: 2022-12-02
Estimated Completion Date: 2026-08
Participants
Target number of participants: 25000
Treatments
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
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
Sponsors
Leads: Chiesi Farmaceutici S.p.A.

This content was sourced from clinicaltrials.gov