A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (MDI) Relative to Budesonide and Formoterol Fumarate MDI and Symbicort® pMDI in Adult and Adolescent Participants with Inadequately Controlled Asthma (LOGOS)
This research study is testing a new type of inhaler for adults who have asthma that isn't fully controlled by their current medication. The main aim is to find out if a new inhaler, called Trixeo Aerosphere (which contains a combination of three medicines: budesonide, glycopyrronium, and formoterol fumarate), is better and safer than existing inhalers like Symbicort. Researchers will compare these inhalers to see which one helps people breathe easier and prevents asthma attacks over a period of 24 to 52 weeks. The study also looks at how quickly the new inhaler starts to work and whether it improves a person's quality of life. This is a common type of study in medicine known as a Phase III trial.
At a glance
What is this study about?
This study is for adults and teenagers (aged 18 and older) who live with asthma that isn't fully under control. This means that even with their current treatment, they might still experience asthma symptoms or flare-ups. The study wants to find out if a new combination inhaler, called Trixeo Aerosphere, can improve breathing and reduce the number of severe asthma attacks compared to other inhalers already available, such as Symbicort.
The researchers will compare the new inhaler with existing treatments over several months, sometimes up to a year. They'll be looking closely at how well people's lungs work, measured by how much air they can breathe out in one second (this is known as FEV1). They will also count how often people have asthma attacks and look at how the treatments affect their daily lives and overall well-being. This is a 'Phase 3' study, which means it's one of the last steps before a new medicine might become widely available.
Finding better ways to control asthma is really important because it can significantly improve someone's quality of life, reduce hospital visits, and help them to be more active. This study aims to provide clear information about the effectiveness and safety of a new treatment option for people whose asthma is difficult to manage.
Key takeaways
- Tests a new inhaler for adults with hard-to-control asthma.
- Compares the new inhaler to existing treatments.
- Aims to improve breathing and reduce asthma attacks.
- Participation involves regular visits and breathing tests.
- This is a Phase 3 study, meaning it's a final step before potential wide use.
- Your health will be closely monitored throughout.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older.
You must have asthma that is not fully controlled, even though you are currently taking asthma medication. This means you might still have symptoms or asthma attacks despite your usual treatment.
The study is open to both men and women.
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 asthma that isn't fully controlled by your current medication?
- Are you willing to attend regular clinic visits for about 6-12 months?
- Are you comfortable using an inhaler as part of a study?
What does participation involve?
If you join this study, you will be given one of the study inhalers. Some people will receive the new combination inhaler, while others will receive an existing inhaler or a dummy inhaler (placebo) to ensure fair comparison. You will use this inhaler as instructed by the study team.
Over the course of 24 to 52 weeks, you will have regular visits to the study clinic. These visits will involve breathing tests (like the FEV1 test) to check how well your lungs are working. You will also be asked about your asthma symptoms, any side effects you experience, and how your asthma affects your daily life by filling out questionnaires.
Throughout the study, you may also be given rescue medication, like Salbutamol, to use if you have an asthma flare-up. The team will monitor your health closely, and your progress will be tracked. The total duration of your involvement in the study will be between 24 weeks (about 6 months) and 52 weeks (about 1 year).
Potential risks and benefits
Locations (5)
- —UnverifiedPortugal
- —UnverifiedGreece
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedSlovakia
Common questions
What is 'inadequately controlled asthma'?
This means your asthma symptoms aren't fully managed by your current medication, and you might still have breathing difficulties, wheezing, or asthma attacks.
What does 'double-blind' mean?
It means neither you nor your study doctor will know which specific treatment you are receiving. This helps make the study fair and unbiased.
What is FEV1?
FEV1 stands for 'Forced Expiratory Volume in 1 second.' It's a common breathing test that measures how much air you can forcefully exhale in one second, showing how well your lungs are working.
Will I have to pay to be in this study?
No, all study-related treatments, medical exams, and tests will be provided at no cost to you.
Can I stop being in the study once I've started?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your 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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