A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma
This study is designed to find out if a new medicine, called GB-0895, can help adults and teenagers (aged 18 and over) who have severe asthma that isn't well controlled by their current treatments. Participants will receive either the new drug or a dummy drug (placebo) along with their usual asthma medication. The main goal is to see if GB-0895 can reduce the number of severe asthma attacks over 52 weeks that require strong medications or hospital visits. Researchers also want to see how it affects lung function, quality of life, and daily asthma symptoms. The study aims to make breathing easier and improve overall well-being for people living with severe asthma.
At a glance
What is this study about?
This study is looking into a new treatment for severe asthma, a type of asthma that can be very difficult to manage even with regular medication. The new treatment is called GB-0895, and researchers want to see if it can help reduce severe asthma attacks and improve the lives of people living with this condition. Severe asthma can significantly impact daily life, so finding new and effective treatments is really important.
Participants in the study will be given either GB-0895 or a 'dummy' treatment (called a placebo) alongside their current asthma medications. A placebo looks just like the real drug but doesn't contain any active medicine. This helps researchers compare the effects of the new drug fairly. Neither the participants nor the doctors will know who is getting which treatment until the study ends. This is a common and important way to ensure the study results are as accurate as possible.
The main thing the researchers want to find out is whether GB-0895 can lower the number of severe asthma attacks over a year. A severe asthma attack is defined as one that needs strong steroid medicine (taken by mouth, injection, or through a drip) or requires a visit to the hospital or emergency room. They will also be checking how the new treatment affects lung function, how it impacts your quality of life, how well your asthma is controlled, and changes in your asthma symptoms during the day and night.
Key takeaways
- This study is for adults (18+) with severe uncontrolled asthma.
- It tests a new drug called GB-0895 to see if it reduces severe asthma attacks.
- Participants will receive either the new drug or a dummy drug (placebo).
- The study lasts about one year and involves regular clinic visits.
- Your regular asthma medication will continue during the study.
- You can stop participating at any time.
Who may be eligible?
This study is for adults, from 18 years of age and older, who have severe asthma that isn't currently well-controlled. This means your asthma symptoms are still causing problems even with your current medication. Both men and women can take part in this study.
While the study is generally open to adults aged 18 and up, there will be more specific health requirements that your doctor will discuss with you. These will ensure the study is safe for you and that the results will be clear. For example, your doctor might need to check your medical history to make sure you don't have other health conditions that could interfere with the study or make the new drug unsafe for you.
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.
- I am 18 years old or older.
- I have been diagnosed with severe asthma.
- My asthma is not well-controlled even with my current treatments.
- I am willing to attend regular clinic appointments for about a year.
What does participation involve?
If you join this study, you will likely have regular visits to your study clinic over 52 weeks (about a year). During these visits, you will have various assessments, which may include breathing tests (like checking your FEV1), filling out questionnaires about your asthma and quality of life, and discussing your symptoms. You will also receive either the study medicine (GB-0895) or the dummy medicine (placebo) to take regularly alongside your usual asthma medication. After the main treatment period, there will be some follow-up appointments to check on your health. The total duration of your participation will be roughly one year.
Potential risks and benefits
Locations (10)
- —UnverifiedLatvia
- —UnverifiedHungary
- —UnverifiedBulgaria
- —UnverifiedRomania
- —UnverifiedPortugal
- —UnverifiedNetherlands
- —UnverifiedCroatia
- —UnverifiedGermany
- —UnverifiedGreece
- —UnverifiedCzechia
Common questions
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real study drug but doesn't contain any active medicine. It helps researchers fairly compare the effects of the new drug.
How long will I be in the study?
You will be involved in the study for about 52 weeks, which is roughly one year.
Will I still take my regular asthma medicine?
Yes, you will continue to take your usual asthma medications alongside the study drug (GB-0895) or the placebo.
What is 'severe uncontrolled asthma'?
This means your asthma symptoms are still bothering you a lot, or you're having frequent asthma attacks, even though you are already taking your prescribed asthma medicines.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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