A prospective multicenter placebo-controlled trial to study the efficacy and safety of Tiotropium in preventing severe asthma exacerbations in partial and uncontrolled preschool asthma.
This medical study is designed to find out if a new inhaler medicine, called Tiotropium, can help young children with asthma. Specifically, we're focusing on children whose asthma isn’t fully controlled or who have had severe asthma attacks before. The main goal is to see if Tiotropium can reduce the number and severity of these attacks, meaning fewer hospital visits or needs for strong steroid medicines. We also want to make sure the medicine is safe for young children. Some children in the study will receive the active medicine, while others will receive a dummy inhaler (placebo), so we can compare the effects fairly. This is a common way to test new medicines and find out if they truly work better than no treatment at all.
At a glance
What is this study about?
This research study is about helping young children who have asthma that isn’t well-controlled. Sometimes, with regular treatments, children can still have severe asthma attacks that are really worrying for them and their families. These attacks might mean trips to the hospital or needing strong medicines like steroids to get better.
The study is testing a medicine called Tiotropium, which is given through an inhaler. It’s a new approach for this age group and type of asthma. We want to find out if giving this medicine regularly can stop these severe asthma attacks from happening as often, or even prevent them altogether. It’s also very important to check if the medicine is safe and if children can use it without too many side effects.
To make sure we get clear answers, some children will receive the actual Tiotropium inhaler, and others will receive a 'dummy' inhaler, called a placebo. This helps us compare the two groups fairly and see if the real medicine makes a noticeable difference compared to no active treatment. This type of study, called a Phase III trial, is a crucial step before a new medicine can be widely used.
Key takeaways
- This study tests a new inhaler for young children with poorly controlled asthma.
- It aims to prevent severe asthma attacks and check the medicine's safety.
- Some children get the active medicine, others a dummy inhaler.
- Participation involves using an inhaler daily and keeping a symptom diary.
- Regular clinic visits and some tests are part of the process.
- Your child can leave the study at any point.
Who may be eligible?
This study is open to both boys and girls of any age who have asthma that isn't fully under control. This might mean they still have symptoms often, or have experienced severe asthma attacks even while on their usual asthma medicines.
To be considered, a child must have been diagnosed with asthma by a doctor and have a history of severe asthma attacks. These attacks are usually defined as needing to stay in hospital because of asthma, or needing strong steroid medicines for several days, or a specific type of steroid called Rectodelt®.
It's important that children in the study are able to use an inhaler as instructed, or have a parent or guardian who can help them with it. The study team will review all of a child's medical information to make sure they are a good fit for the study and that it would be safe for them to take 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.
- Is my child of any age with a doctor-diagnosed asthma?
- Does my child's asthma sometimes get severe or is it not fully controlled with current medication?
- Has my child had severe asthma attacks leading to hospitalisation or needing strong steroids?
- Can my child, or can I help them, use an inhaler regularly as instructed?
- Am I willing to keep a daily record of my child's asthma symptoms?
What does participation involve?
If your child joins the study, they will either receive the Tiotropium inhaler or a placebo (dummy) inhaler. You won't know which one they are getting. You'll need to help your child use the inhaler regularly as directed. You'll also be asked to keep a daily diary, electronically or through an app, to record your child's asthma symptoms, how they're sleeping, and if they've needed any 'reliever' medications like salbutamol. There will be regular visits to the clinic so the doctors can check on your child's health, their asthma, and any side effects. They might also take some blood samples to look at things like eosinophils and IgE, which are markers related to asthma and allergies. The total duration of participation and how many visits are needed will be explained fully by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is Tiotropium?
Tiotropium is a medicine given through an inhaler. In this study, we're looking to see if it can help prevent severe asthma attacks in young children.
What does 'placebo' mean?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps us compare the effects of the real medicine fairly.
Will my child definitely get the new medicine?
No, children taking part will be randomly assigned to either receive the Tiotropium inhaler or a placebo inhaler. Neither you nor the study doctors will know which one your child is on.
What is a severe asthma attack in this study?
In this study, a severe asthma attack means an episode that requires your child to be hospitalised, or needs strong steroid medicines for at least three days, or a specific rectal steroid called Rectodelt®.
How long will my child be in the study?
The exact length of time will be explained by the study team, but it involves regular use of the inhaler and clinic visits over a period to monitor your child's asthma.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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