PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)
This study, called a Post Authorisation Safety Study (PASS), is checking on the safety of a new 'triple therapy' medicine for people with Chronic Obstructive Pulmonary Disease (COPD). This therapy comes in two different types of inhalers: a Dry Powder Inhaler (DPI) and a pressurized Metered Dose Inhaler (pMDI). Researchers want to see if starting one type of inhaler versus the other makes any difference in the risk of heart attacks, strokes, or other heart-related issues. They are doing this by looking at existing health records from several European countries, including the UK, rather than conducting new tests on patients. The main idea they are exploring is that both inhaler types are equally safe regarding these heart and brain health problems.
At a glance
What is this study about?
This study is called a Post Authorisation Safety Study, or PASS. It's a way for researchers to keep an eye on medicines once they are already available to patients. In this case, they are focusing on people with Chronic Obstructive Pulmonary Disease (COPD) who are just starting a new kind of inhaler medicine called 'fixed triple therapy.' This medicine combines three different drugs in one inhaler.
The main goal is to compare two common ways this triple therapy can be given: using a Dry Powder Inhaler (DPI) or a pressurized Metered Dose Inhaler (pMDI). The researchers want to find out if one type of inhaler is linked to more or fewer problems related to the heart or blood vessels in the brain (like strokes) than the other. They are looking at existing health information from real-life medical care, so no one will be given a new treatment just for this study.
This is an 'observational' study, meaning researchers are simply looking at what has already happened in people's medical records. They are trying to see if there's any difference in heart and brain health issues for those who started with a DPI compared to those who started with a pMDI. The researchers are starting with the idea that both inhaler types will have similar safety profiles regarding these specific events, and they will be checking the existing data to see if that holds true.
Key takeaways
- This study looks at the safety of two types of inhalers for COPD.
- It checks for risks of heart or stroke-related problems.
- Researchers use existing health records, so you don't do anything extra.
- The goal is to understand if one inhaler type is safer than the other.
- The study includes data from several European countries, including the UK.
Who may be eligible?
To be included in this study, people must have been diagnosed with COPD and be 40 years old or older. A key requirement is that they must be new to a specific type of 'triple therapy' inhaler, either a Dry Powder Inhaler (DPI) or a pressurized Metered Dose Inhaler (pMDI).
People would not be included if they had already been using a 'triple therapy' inhaler in the 90 days before starting the specific study treatment. Also, if they had been in hospital for a heart-related problem in the 30 days before starting the treatment, they would not be eligible.
- Do you have a diagnosis of COPD?
- Are you 40 years old or older?
- Are you new to a 'triple therapy' inhaler (DPI or pMDI)?
- Have you NOT used a 'triple therapy' inhaler in the last 3 months?
- Have you NOT been in hospital for a heart problem in the last month?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you are part of this study, you won't need to do anything extra. This isn't a study where you get a new medicine or have extra appointments. Instead, researchers are looking at information already in existing health records from your regular medical care. They will follow information about your health from when you started your 'triple therapy' inhaler until the end of your treatment, if you switch to a different medicine, or for a set period. You won't have any direct contact with the research team.
Potential risks and benefits
Locations (1)
- Clinical Practice Research Datalink (CPRD)London, United Kingdom· Recruiting
Common questions
What is 'triple therapy' for COPD?
It's a type of inhaler medicine that combines three different drugs to help manage COPD symptoms in one device.
What's the difference between a DPI and a pMDI?
They are just two different ways for the inhaler medicine to be delivered into your lungs. A DPI is a dry powder inhaler, and a pMDI is a pressurized 'puff' inhaler.
Will I have to take new medicine for this study?
No, this study only looks at information from people who are already using these inhalers as part of their regular medical treatment. You don't take any new medicine just for the study.
Will this study affect my current treatment?
No, this study will not affect your current treatment or care in any way. It's simply observing existing data.
Who is funding this study?
The information provided does not specify the funding source, but these types of studies are often funded by pharmaceutical companies who make the medicines being studied.
How to find out more
Clinical Trial Info
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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