In short
A multinational Phase IIIb clinical trial is underway to assess the safety and efficacy of STALORAL® Birch 300 IR, a Betula Pollen Extract, in treating birch pollen-induced allergic rhinoconjunctivitis (ARC) in children and adolescents aged 5 to 17 years. This double-blind, placebo-controlled study aims to demonstrate the drug's effectiveness in reducing ARC symptoms and the need for rescue medication during birch pollen seasons.
At a glance
- Study Type
- Phase IIIb, Double-blind, Placebo-controlled Trial
- Medication
- STALORAL® Birch 300 IR (Betula Pollen Extract)
- Target Population
- Children and Adolescents aged 5-17 years
- Condition
- Birch Pollen-induced Allergic Rhinoconjunctivitis (with or without Asthma)
- Primary Objective
- Demonstrate clinical efficacy on ARC symptoms and rescue medication use
- Secondary Objectives
- Assess effects on symptoms, medication use, quality of life, asthma status, oral allergy syndrome, and immunological status
- Duration
- Two consecutive birch pollen seasons
- Key Inclusion Criteria
- Moderate to severe ARC history, positive skin prick test, specific IgE levels
- Key Exclusion Criteria
- Severe asthma, recent use of certain medications, significant health conditions
- Primary Endpoint
- Average ARC Total Combined Score over the entire second Birch Pollen Season
What is STALORAL® Birch?
STALORAL® Birch is a medication used to treat allergies caused by birch pollen. It contains an extract from birch pollen, also known as Betula pollen extract. This medication is available as an oromucosal solution, which means it's a liquid that is applied in the mouth, specifically under the tongue (sublingual use).
Medical Conditions Treated
STALORAL® Birch is primarily used to treat birch pollen-induced allergic rhinoconjunctivitis. This condition involves: Allergic rhinitis: Inflammation of the nasal passages, causing symptoms like sneezing, runny nose, and nasal congestion. Conjunctivitis: Inflammation of the eye, leading to symptoms such as itchy, red, or watery eyes. The medication can be used in children and adolescents aged 5 to 17 years who have this condition, with or without asthma.
How STALORAL® Birch Works
STALORAL® Birch is a type of treatment called allergen immunotherapy. It works by gradually exposing your body to small amounts of birch pollen extract. Over time, this can help your immune system become less sensitive to birch pollen, reducing allergic reactions when you're exposed to it in the environment.
Clinical Trial Information
A clinical trial is being conducted to assess the safety and effectiveness of STALORAL® Birch in children and adolescents. Here are some key points about the trial: It's a Phase IIIb trial, which means it's an advanced stage of testing before the medication can be approved for widespread use. The trial is double-blind and placebo-controlled, meaning neither the patients nor the doctors know who is receiving the real medication or a placebo (a substance with no active ingredients). The main goal is to show how well STALORAL® Birch works in reducing allergy symptoms and the need for other allergy medications during birch pollen season. The trial will also look at how the medication affects quality of life, asthma control, and the immune system's response over two birch pollen seasons.
Eligibility Criteria
To participate in the trial, children and adolescents must meet certain criteria. Some key points include: Age: Between 5 and 17 years old. History of moderate to severe allergic rhinoconjunctivitis caused by birch pollen. Positive skin prick test and blood test for birch pollen allergy. For those with asthma, it must be mild to moderate and well-controlled. There are also several conditions that would prevent participation, such as severe asthma, certain other medical conditions, or use of certain medications.
Potential Benefits
If effective, STALORAL® Birch may offer several benefits: Reduced allergy symptoms during birch pollen season. Less need for other allergy medications. Improved quality of life during allergy season. Potential improvement in asthma control for those who have both allergies and asthma.
Important Considerations
While STALORAL® Birch shows promise, it's important to remember: It's still being studied, and more research is needed to fully understand its effects. Like all medications, it may have side effects. These will be closely monitored during the trial. It's not suitable for everyone with birch pollen allergies. A doctor would need to determine if it's appropriate based on individual circumstances. The medication contains sodium, which might be a concern for people on low-sodium diets.