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Betula Pollen Extract

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.

Table of Contents

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[1]. 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)[1].

Medical Conditions Treated

STALORAL® Birch is primarily used to treat birch pollen-induced allergic rhinoconjunctivitis[1]. 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[1].

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[1].

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[1].
  • 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)[1].
  • 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[1].
  • 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[1].

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[1].
  • History of moderate to severe allergic rhinoconjunctivitis caused by birch pollen[1].
  • Positive skin prick test and blood test for birch pollen allergy[1].
  • For those with asthma, it must be mild to moderate and well-controlled[1].
There are also several conditions that would prevent participation, such as severe asthma, certain other medical conditions, or use of certain medications[1].

Potential Benefits

If effective, STALORAL® Birch may offer several benefits:

  • Reduced allergy symptoms during birch pollen season[1].
  • Less need for other allergy medications[1].
  • Improved quality of life during allergy season[1].
  • Potential improvement in asthma control for those who have both allergies and asthma[1].

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[1].
  • Like all medications, it may have side effects. These will be closely monitored during the trial[1].
  • It’s not suitable for everyone with birch pollen allergies. A doctor would need to determine if it’s appropriate based on individual circumstances[1].
  • The medication contains sodium, which might be a concern for people on low-sodium diets[1].

Aspect Details
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

FAQ

  • What is the purpose of this clinical trial? The main purpose is to demonstrate the clinical efficacy of STALORAL® Birch 300 IR in reducing allergic rhinoconjunctivitis (ARC) symptoms and the need for rescue medication in children and adolescents with birch pollen-induced ARC during the birch pollen season.
  • Who can participate in this trial? Children and adolescents aged 5 to 17 years with a documented history of moderate to severe allergic rhinoconjunctivitis caused by birch pollen can participate. They must meet specific criteria, including positive skin prick tests and IgE levels to birch pollen allergens.
  • How long does the trial last? The trial spans over two consecutive birch pollen seasons, allowing researchers to assess the drug's effectiveness and safety over an extended period.
  • What will be measured during the trial? The trial will measure various factors, including ARC symptoms, medication use, quality of life, changes in ARIA classification, asthma status, oral allergy syndrome, and immunological status of patients over two birch pollen seasons.
  • Are there any restrictions for participants? Yes, there are several exclusion criteria. For example, participants cannot have severe or uncontrolled asthma, recent use of certain medications, or other significant health conditions that could increase risk or interfere with the study results.

Ongoing Clinical Trials on Betula Pollen Extract

  • Study of sublingual birch pollen extract (SLI-RX-BET) in different doses for patients with moderate to severe allergic rhinitis caused by birch pollen

    Not yet recruiting

    1 1
    Investigated drugs:
    Germany

  • Study on the Safety and Effectiveness of Betula Pollen Extract for Children and Adolescents Aged 5-17 with Birch Pollen Allergies and Possible Asthma

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria Bulgaria Finland France Germany Hungary +6

Glossary

  • Allergic Rhinoconjunctivitis (ARC): A condition where the nose and eyes become inflamed due to an allergic reaction, typically causing symptoms such as sneezing, runny nose, and itchy, watery eyes.
  • STALORAL® Birch 300 IR: The investigational drug being tested in this trial, which contains Betula Pollen Extract for the treatment of birch pollen-induced allergic rhinoconjunctivitis.
  • Birch Pollen Season (BPS): The time of year when birch trees release pollen, typically causing allergic reactions in sensitive individuals.
  • Immunoglobulin E (IgE): A type of antibody that plays a crucial role in allergic reactions. In this trial, specific IgE levels to birch pollen allergens are measured.
  • Skin Prick Test (SPT): A method used to diagnose allergies by observing the skin's reaction to small amounts of potential allergens.
  • Forced Expiratory Volume in 1 second (FEV1): A measure of lung function, specifically how much air a person can exhale in one second after taking a deep breath.
  • Quality of Life (QOL): A measure of an individual's overall well-being and ability to function in daily life, which can be affected by allergic conditions.
  • Oral Allergy Syndrome (OAS): A condition where certain foods cause an allergic reaction in the mouth and throat, often related to pollen allergies.
  • ARIA classification: Allergic Rhinitis and its Impact on Asthma (ARIA) is a system used to classify the severity and duration of allergic rhinitis symptoms.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-betula-pollen-extract-for-children-and-adolescents-aged-5-17-with-birch-pollen-allergies-and-possible-asthma/