Assessing cardiovascular and cerebrovascular events in COPD patients using different inhalers
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
This study is trying to see if using a Dry Powder Inhaler is safer than a Metered Dose Inhaler for older adults with COPD by looking at heart and brain-related health issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Chiesi Farmaceutici S.p.A. Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT05652439 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are COPD patients aged 40 and older who are new users of inhaled fixed triple therapy.
Not a fit: Patients who have recently used any form of triple therapy or have had cardiovascular hospitalization in the past 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety of different inhaler devices for COPD patients, potentially guiding treatment choices.
How similar studies have performed: Other studies have explored similar safety assessments in COPD treatments, but this specific comparison of DPI and pMDI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.