A Multi-national Phase IIIb, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of STALORAL® Birch 300 IR in Children and Adolescents 5 to 17 Years old with Birch Pollen-induced Allergic Rhinoconjunctivitis with or without Asthma
This study is looking into a new medicine called STALORAL® Birch for children and teenagers between 5 and 17 years old. These young people all suffer from hay fever, also known as allergic rhinoconjunctivitis, which is triggered by birch pollen. Some of them also have asthma. The main goal of the study is to see how well STALORAL® Birch works compared to a dummy treatment (placebo) and to find out if it's safe to use. Researchers hope to understand if this treatment can reduce the runny nose, sneezing, and itchy eyes associated with birch pollen allergies, and whether it might also help those who experience asthma symptoms during birch pollen season.
At a glance
What is this study about?
This study is about a new treatment called STALORAL® Birch, designed for children and teenagers aged 5 to 17 who get hay fever from birch pollen. Hay fever, or allergic rhinoconjunctivitis, causes symptoms like sneezing, a runny or blocked nose, and itchy, watery eyes. Some young people in this study also have asthma, which can sometimes be made worse by pollen.
The study is trying to find out if STALORAL® Birch is a safe and effective way to help reduce these symptoms. For comparison, some participants will receive the active treatment, while others will receive a dummy treatment (a placebo) that looks and tastes the same. This allows the researchers to fairly assess how well the actual medicine works.
The main thing researchers will be looking at is how much the participants' hay fever symptoms improve. They will also look at how these symptoms affect daily life, such as sleep, school, or playtime, and for teenagers, how it affects their overall wellbeing. By carefully comparing the groups, the study aims to confirm if STALORAL® Birch can make a real difference for young people with birch pollen allergies and their related symptoms.
Key takeaways
- Study for children and teenagers (5-17) with birch pollen hay fever.
- Investigates a new treatment called STALORAL® Birch.
- Looks at safety and how well it reduces hay fever symptoms.
- Compares the active treatment to a dummy treatment (placebo).
- May also assess impact on asthma if present.
- Participation involves taking medicine and regular symptom checks.
Who may be eligible?
To be part of this study, participants need to be children or teenagers between 5 and 17 years old. They must suffer from hay fever (allergic rhinoconjunctivitis) specifically caused by birch pollen. This means that when birch pollen is in the air, they experience symptoms like sneezing, a runny or blocked nose, or itchy eyes.
The study includes young people who only have birch pollen hay fever, as well as those who also have asthma alongside their hay fever. Gender does not affect eligibility; both boys and girls can take part. Specific medical checks will be done by the study team to make sure it's safe and appropriate for each potential participant to join.
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 between 5 and 17 years old?
- Does my child suffer from hay fever symptoms (sneezing, runny nose, itchy eyes)?
- Are these hay fever symptoms mainly caused by birch pollen?
- Has my child been diagnosed with birch pollen allergy by a doctor?
- Is my child willing to take a study medicine by mouth?
- Am I, as a parent or guardian, willing for my child to attend regular appointments for assessments?
What does participation involve?
If you decide to take part, your child would be given a study medicine to use. This medicine is a solution that is placed in the mouth. It will either be the active treatment, STALORAL® Birch, or a dummy treatment (placebo). Neither you nor the study team will know which one your child is receiving.
Throughout the study, your child will have regular assessments. This will involve answering questions about their hay fever symptoms, how severe they are, and how they affect daily activities. There will likely be clinic visits to see the study doctors and nurses who will monitor your child's health and any changes in their symptoms. The total duration of the study would be explained by the research team, but it will cover at least one birch pollen season to see how the treatment works when pollen is present.
Potential risks and benefits
Locations (12)
- —UnverifiedFinland
- —UnverifiedSlovakia
- —UnverifiedGermany
- —UnverifiedSweden
- —UnverifiedAustria
- —UnverifiedRomania
- —UnverifiedHungary
- —UnverifiedLatvia
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedBulgaria
- —UnverifiedLithuania
Common questions
What is 'allergic rhinoconjunctivitis'?
It's the medical term for hay fever, which causes symptoms like sneezing, a runny nose, and itchy, watery eyes, usually seasonally.
What does 'birch pollen-induced' mean?
This means your child's hay fever is specifically triggered by pollen from birch trees.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare the real treatment fairly.
Why include children who have asthma?
Sometimes, hay fever and asthma are linked. The study wants to see if this treatment can also help with asthma symptoms in children with birch pollen allergy.
How is the medicine given?
The medicine is a liquid solution that is placed in the mouth, usually under the tongue.
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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