At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Observational retrospective data collection (other)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- Observational retrospective data collection — other: Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 40 Years and over
- Who
- All
- Number of participants
- 25,000
- Started
- 2022-12-02
- Last checked
- 2025-04
Plain English Summary
What is this study?
- • Testing a new treatment for chronic obstructive pulmonary disease
- • Clinical study - 25,000 participants
- • 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)
Who can take part?
- • Ages 40 Years and over
- • Diagnosed with chronic obstructive pulmonary disease
Where?
- • London - Clinical Practice Research Datalink (CPRD)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Non-interventional, multi-country cohort study to assess the incidence of adverse cardiovascular and cerebrovascular events among patients with chronic obstructive pulmonary disease (COPD), exposed to inhaled fixed triple therapy BDP/FF/GB via DPI (drug of interest) or pMDI (comparator). The study will be conducted based on secondary health data collected (as per clinical practice) retrospectively from seven different European data sources in the following countries: United Kingdom, Germany, The Netherlands, Denmark, Sweden, Norway and Finland. Patients in the two exposure groups of this Post Authorisation Safety Study (PASS) will be followed for the study outcomes from the start of the exposure until the first occurrence of end of treatment, switch to the other study drug, end of the study period, or censoring. The pre-defined hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗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...
- ✗Hospitalization due to cardiovascular causes in the previous 30 days before the index date.
See the full criteria
Where Is This Study? (1 UK site)
Clinical Practice Research Datalink (CPRD)
London, United Kingdom
How to Get in Touch
Clinical Trial Info
Sponsor contactCONTACT