NCT05652439 PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
| NCT ID | NCT05652439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 25,000 participants |
| Start Date | 2022-12-02 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25,000 participants in total. It began in 2022-12-02 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Fabian Hoti
PRINCIPAL INVESTIGATOR
IQVIA Pty Ltd
Frequently Asked Questions
Who can join the NCT05652439 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05652439 currently recruiting?
Yes, NCT05652439 is actively recruiting participants. Contact the research team at clinicaltrials_info@chiesi.com for enrollment information.
Where is the NCT05652439 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05652439 clinical trial?
NCT05652439 is sponsored by Chiesi Farmaceutici S.p.A.. The principal investigator is Fabian Hoti at IQVIA Pty Ltd. The trial plans to enroll 25,000 participants.