A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) With the Fixed Dose Dual Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate (CHF 1535), Both Administered Via pMDI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This one-year study is looking at a new combination inhaler for Chronic Obstructive Pulmonary Disease (COPD). It compares a potential new treatment, which has three medicines in one inhaler, against a current treatment that has two medicines. Researchers want to see if the new three-in-one inhaler can improve breathing more effectively, reduce flare-ups, and generally make people feel better. They will also carefully check for any side effects. This study aims to find out if this new inhaler could be a helpful option for people living with COPD.
At a glance
What is this study about?
Imagine your lungs are like a tree with many branches, where air normally flows in and out easily. With Chronic Obstructive Pulmonary Disease (COPD), these air passages can become narrowed and inflamed, making it hard to breathe. People with COPD often experience breathlessness, coughing, and wheezing. This research study is testing a new combination inhaler designed to help manage these symptoms and improve breathing.
Currently, many people with COPD use inhalers that combine two different medications to help open their airways and reduce inflammation. This study is exploring a new inhaler that combines three medicines into one – think of it as a 'three-in-one' solution. The main goal is to compare this new inhaler with a standard 'two-in-one' inhaler that already exists. Researchers want to find out if the new three-in-one inhaler can improve lung function (how much air you can breathe out) more than the two-in-one inhaler. They will also check if it can reduce COPD flare-ups, which are times when symptoms get much worse.
Beyond improving breathing, the study will also look at how participants feel about their breathing difficulties and overall quality of life. Importantly, they will be very careful to record any side effects or unwanted reactions to the medications. By gathering all this information over a year, scientists hope to determine if this new three-in-one inhaler could be a safe and effective treatment option for people with COPD, potentially offering a simpler way to manage their condition.
Key takeaways
- Tests a new 'three-in-one' inhaler for COPD.
- Compares it to an existing 'two-in-one' inhaler.
- Aims to improve breathing and reduce flare-ups.
- Checks for safety and side effects over one year.
- Open to adults aged 18 and over with COPD.
- Participation includes regular clinic visits and using the inhaler daily.
Who may be eligible?
To join this study, you need to be an adult, 18 years or older. Both men and women are welcome to take part.
You would need to have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD). The study team will check your specific medical history and lung test results to make sure it's suitable for you. There might be some other health conditions or medications that would prevent you from joining, as the researchers need to ensure the study is safe for everyone involved and that they get clear results.
If you're interested, the first step is to talk to your doctor or the study team. They will go through a full list of things to see if this study is the right fit for you.
- Are you 18 years old or older?
- Have you been diagnosed with Chronic Obstructive Pulmonary Disease (COPD)?
- Are you currently using an inhaler for your COPD?
- Are you willing to attend regular clinic appointments for one year?
- Are you comfortable not knowing which study inhaler you are receiving?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be using an inhaler daily for about one year (52 weeks). You wouldn't know if you're receiving the new three-in-one inhaler or the existing two-in-one inhaler, nor would the doctors treating you. This is called a 'double-blind' study to ensure fair results. You would be given an inhaler and taught how to use it correctly.
Throughout the year, you would have regular appointments at the clinic. At these visits, doctors and nurses would check your breathing using special tests, ask about your symptoms, and see how you're feeling. They will also keep a close eye on your health and record any side effects you might experience. These visits help the researchers understand how the inhalers are working and ensure your safety. The study involves taking your medication as instructed and attending all scheduled check-ups.
Potential risks and benefits
Locations (5)
- —Hungary
- —Poland
- —Czechia
- —Bulgaria
- —Romania
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that makes it difficult to breathe, often causing breathlessness, coughing, and wheezing.
What is an inhaler?
An inhaler is a small device that delivers medicine directly into your lungs to help open airways and reduce inflammation, making breathing easier.
What does 'double-blind' mean?
Double-blind means neither you nor your doctor will know which specific inhaler you are using during the study. This helps ensure the results are fair and unbiased.
How long will I be in the study?
If you join, you would be taking part in the study and using the inhaler for about one year (52 weeks).
Can I leave the study at any time?
Yes, you are free to leave the study at any point, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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