Assessing cardiovascular and cerebrovascular events in COPD patients using different inhalers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the incidence of adverse cardiovascular and cerebrovascular events in patients with chronic obstructive pulmonary disease (COPD) who are new users of inhaled fixed triple therapy. It compares the safety profile of the Dry Powder Inhaler (DPI) against the pressurized Metered Dose Inhaler (pMDI). Data will be collected retrospectively from various European health databases, focusing on patients aged 40 and older who have been diagnosed with COPD. The study will track outcomes from the initiation of therapy until certain predefined endpoints.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Practice Research Datalink (CPRD)
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Fabian Hoti — IQVIA Pty Ltd
• Study coordinator: Clinical Trial Info
• Email: clinicaltrials_info@chiesi.com
• Phone: +3905212791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.