Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma
This study is investigating a new medicine called glycopyrronium for children aged 6 to 11 who have asthma. The main goal is to understand how two different doses of this inhaled medicine affect breathing, how much of it gets into the body, and if it's safe and well-tolerated compared to a dummy medicine (placebo). The findings from this research will help decide the best dose of glycopyrronium to include in a new combination asthma inhaler (called indacaterol/mometasone/glycopyrronium) that’s currently being developed. This new combination aims to provide more effective treatment for children with moderate to severe asthma, helping them breathe better and manage their condition.
At a glance
What is this study about?
This study is looking into a new inhaled medicine called glycopyrronium for children aged 6 to 11 who have asthma. We want to understand how it affects their breathing and whether it's safe to use. Currently, researchers are developing a new combination asthma inhaler which will include glycopyrronium, and this study will help them choose the right dose for children.
The main idea behind this research is to see if glycopyrronium helps children with asthma breathe more easily. Asthma can make breathing difficult, and medicines that open up the airways (bronchodilators) are very important. We will compare two different doses of glycopyrronium with a 'dummy' inhaler (placebo) to see which dose is most effective and how well children tolerate it. This sort of research is crucial to make sure new medicines are both safe and helpful for children.
Ultimately, the results of this study will guide the development of a new, triple-combination asthma treatment. This investigational new medicine is designed to combine several active ingredients into one inhaler to potentially offer a more effective way to manage asthma symptoms for children with moderate to severe asthma. By carefully studying glycopyrronium now, we can ensure that future treatments are well-suited for young patients.
Key takeaways
- This study is testing different doses of a new asthma medicine (glycopyrronium) for children aged 6-11.
- It aims to find a safe and effective dose for a new combination asthma inhaler.
- Children will try the study medicine, different doses, and a 'dummy' inhaler over 10 weeks.
- The total study duration, including follow-up, is about 20 weeks.
- Parents must give consent, and guardians need to support children with study tasks.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for children aged between 6 and 11 years old who have had a confirmed asthma diagnosis for at least six months. They should be taking a stable dose of their usual asthma controller medicines (like an inhaled steroid) for at least four weeks before starting the study.
We would also need to check that their lung function is within a specific range, meaning their asthma isn't too mild or too severe for this particular study. There will be some breathing tests to confirm this. Importantly, a parent or legal guardian must be able to give permission and be available to help the child with study activities and attend all appointments.
Children invited to participate must also be able to correctly use an inhaler and perform breathing tests properly. If a child is female and could potentially become pregnant, their parents would need to ensure suitable contraception is used throughout the study.
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.
- Is your child between 6 and 11 years old?
- Does your child have a confirmed diagnosis of asthma for at least 6 months?
- Is your child currently using a stable dose of regular asthma controller medicine?
- Are you, as a parent/guardian, able to attend appointments and help with study tasks?
- Can your child perform breathing tests and use an inhaler correctly?
What does participation involve?
If your child takes part, the study will last about 20 weeks in total. This includes an initial check-up phase, a 'run-in' period, the main treatment phase, and a final follow-up.
During the treatment phase, which lasts 10 weeks, your child will try three different inhalers: two different doses of the study medicine (glycopyrronium) and a 'dummy' inhaler (placebo). They will use each inhaler for two weeks, with a two-week break (wash-out period) in between to make sure the effects of the previous medicine have worn off. Your child will continue to use their usual asthma controller medicine throughout the study.
There will be regular clinic visits where your child will have their breathing checked and their general health monitored. A parent or guardian will also need to complete electronic diaries about the child's symptoms and medicine use. After their last dose of study medicine, there will be a final check-up and a follow-up phone call about a month later to ensure everything is well.
Potential risks and benefits
Locations (23)
- Novartis Investigative SiteVerified postcodeRousse, Bulgaria· Recruiting
- Novartis Investigative SiteVerified postcodeSevlievo, Bulgaria· Recruiting
- Novartis Investigative SiteVerified postcodeSofia, Bulgaria· Recruiting
- Novartis Investigative SiteVerified postcodeIbague, Colombia· Recruiting
- Novartis Investigative SiteVerified postcodeGuatemala City, Guatemala· Withdrawn
- Novartis Investigative SiteVerified postcodeGuatemala City, Guatemala· Recruiting
- Novartis Investigative SiteVerified postcodeDebrecen, Hungary· Recruiting
- Novartis Investigative SiteVerified postcodeBudapest, Hungary· Recruiting
- Novartis Investigative SiteVerified postcodeBudapest, Hungary· Recruiting
- Novartis Investigative SiteVerified postcodeEger, Hungary· Recruiting
- Novartis Investigative SiteVerified postcodeKaposvár, Hungary· Withdrawn
- Novartis Investigative SiteVerified postcodeNagykanizsa, Hungary· Withdrawn
Common questions
What is glycopyrronium?
Glycopyrronium is a type of medicine that helps to open up the airways in the lungs, making it easier to breathe for people with asthma.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks exactly like the real medicine but contains no active ingredients. It helps researchers understand the true effects of the actual medicine.
Why are children doing breathing tests?
Breathing tests, like FEV1, measure how much air your child can breathe out quickly. This helps us understand how well their lungs are working and how the medicine is affecting them.
Will my child continue their usual asthma medicine?
Yes, children in this study will continue to take their regular background asthma controller medicine in addition to the study inhalers.
How long will the study appointments take?
The study involves regular visits over approximately 20 weeks. Specific visit durations will be explained in detail by the study team.
How to find out more
Novartis Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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