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Clinical Trial Info +3905212791
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Be Part of Research - Trial Details - PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)

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

Recruiting

Open to: ALL

Age: 40.0 - N/A

Medical Conditions

Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2022 Aug 2026

OBSERVATIONAL

Intervention Type : OTHER
Intervention Description : Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes

Intervention Arm Group : Fixed triple therapy BDP/FF/GB via DPI;Fixed triple therapy BDP/FF/GB via pMDI;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Clinical Practice Research Datalink (CPRD)
    London


The study is sponsored by Chiesi Farmaceutici S.p.A.




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Read full details for Trial ID: NCT05652439
Last updated 30 April 2025

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