A pragmatic, phase IV, randomized, open-label, multinational, multicentre, 2-arm parallel group, prospective study comparing efficacy and safety of Single Inhaler ICS/LABA/LAMA (beclometasone/formoterol fumarate/glycopyrronium bromide [87/5/9 pMDI {BD/FF/GB - 100/6/12.5 µg}]) vs Single Inhaler ICS/LABA (beclometasone dipropionate plus formoterol fumarate [200/6 pMDI {BD/FF - 200/6 µg}]) in asthma subjects.
This research study is looking at two different inhaler treatments for adults with asthma: Trimbow and Fostair. The main goal is to see which inhaler works better at controlling asthma symptoms and preventing asthma flare-ups over a 12-month period. Researchers will also be checking the safety of both inhalers to ensure they don't cause too many side effects. This is a common type of study that helps doctors understand the best ways to treat asthma in everyday situations, building on knowledge already gained from earlier studies. Participants will be taking one of these inhalers and having regular check-ups.
At a glance
What is this study about?
This study aims to compare two commonly used inhalers for people living with asthma: Trimbow and Fostair. Both inhalers are already approved and widely used, but this study will help us understand which one might be more effective in managing asthma symptoms and preventing serious flare-ups in a real-world setting. Researchers want to see how these treatments compare over a year.
The main thing the study will measure is how much participants' asthma symptoms improve over the year. They'll also closely monitor how often people have asthma flare-ups and how severe these flare-ups are. Beyond symptoms, the study will check things like lung function, how well people stick to their inhaler use, and how asthma affects their daily life and general well-being.
By comparing these two established treatments, the study hopes to provide valuable information that can help doctors and patients make better decisions about which inhaler might be most suitable for managing asthma effectively and safely.
Key takeaways
- This study compares two commonly used asthma inhalers: Trimbow and Fostair.
- It aims to find out which inhaler is more effective for controlling asthma symptoms and preventing flare-ups.
- The study involves adult asthma patients and lasts for 12 months.
- You will know which inhaler you are using if you participate.
- Regular visits and checks will monitor your asthma and overall health.
- This research helps improve future asthma treatment choices.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women can take part. The study is specifically for people who have been diagnosed with asthma.
There will be other specific health requirements that your doctor will check to make sure the study is a good fit for you. These might include details about your current asthma treatment, other health conditions you might have, and any medications you are taking.
It's important that you discuss your full medical history with the study team to confirm if you meet all the requirements for taking part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of asthma?
- Are you able to attend regular study appointments for 12 months?
- Are you willing to use one of the two study inhalers?
- Are you comfortable filling out questionnaires about your asthma?
What does participation involve?
If you join the study, you will be given either the Trimbow inhaler or the Fostair inhaler to use for 12 months. This is a 'two-arm parallel group' study, meaning you will be assigned to one of the two treatment groups at random, and you will stay with that treatment for the entire study period. You and your doctor will know which inhaler you are using (this is called 'open-label').
You will have several study visits at a clinic or hospital over the course of the year. These visits will involve various tests and questionnaires. For example, your asthma symptoms will be checked using a questionnaire called ACQ-5. Your lung function will be measured using breathing tests, and blood samples might be taken to check certain markers related to asthma.
You will also be asked about any asthma flare-ups, how well you are taking your inhaler, and how your asthma affects your quality of life. The study will last for a total of 12 months, with regular follow-up visits to monitor your progress and safety.
Potential risks and benefits
Locations (8)
- —UnverifiedGermany
- —UnverifiedRomania
- —UnverifiedItaly
- —UnverifiedBulgaria
- —UnverifiedPoland
- —UnverifiedSlovakia
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What is the main goal of this study?
The main goal is to compare two existing asthma inhalers (Trimbow and Fostair) to see which is better at controlling asthma symptoms and preventing flare-ups over a year.
Who can take part in this study?
Adults aged 18 and over who have asthma can potentially take part. Your study doctor will check other specific health requirements.
Will I know which inhaler I'm using?
Yes, both you and your doctor will know whether you are using the Trimbow or Fostair inhaler throughout the study.
How long will I be in the study?
If you join, you will be part of the study for 12 months, with regular check-up visits.
What are 'asthma flare-ups'?
Asthma flare-ups, or exacerbations, are periods when your asthma symptoms get much worse and might need extra treatment like steroids or even a hospital visit.
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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