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Betula Verrucosa (108)

This article discusses the use of Betula Verrucosa (108), commonly known as birch pollen extract, in clinical trials for treating birch pollen allergies. We’ll explore a phase II-III study that aims to assess the efficacy and safety of sublingual immunotherapy using this extract for patients suffering from moderate-to-severe allergic rhinitis or rhinoconjunctivitis due to birch pollen.

Table of Contents

What is BETULA VERRUCOSA (108)?

BETULA VERRUCOSA (108), also known as BETULA VERRUCOSA (PENDULA) (108) or 108 BETULA VERRUCOSA, is an allergen extract derived from birch pollen[1]. It is being studied as a potential treatment for people with birch pollen allergies. This substance is classified as a “Structurally Diverse Substance – Allergen,” which means it contains various components found in birch pollen that can trigger allergic reactions in sensitive individuals.

Medical Conditions Treated

BETULA VERRUCOSA (108) is primarily being investigated for the treatment of moderate-to-severe allergic rhinitis or rhinoconjunctivitis caused by birch pollen[1]. These conditions involve inflammation of the nasal passages (rhinitis) and/or eyes (conjunctivitis) in response to birch pollen exposure. Symptoms may include:

  • Sneezing
  • Runny or stuffy nose
  • Itchy or watery eyes
  • Itchy throat or ears

To be considered for treatment, patients typically need to have experienced these symptoms for at least two years, as defined by the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline[1].

How It Works

BETULA VERRUCOSA (108) is being studied as a form of sublingual immunotherapy (SLIT)[1]. This treatment approach works by exposing the immune system to small, controlled amounts of the allergen (in this case, birch pollen extract) over time. The goal is to gradually desensitize the immune system, reducing its overreaction to the allergen and alleviating allergy symptoms.

Administration

The medication is administered as a sublingual spray, meaning it is sprayed under the tongue[1]. This method allows for easy absorption of the allergen through the mucous membranes in the mouth. The exact dosage and frequency of administration are still being determined through ongoing clinical trials.

Who Can Use This Treatment?

While the treatment is still under investigation, current studies are focusing on adults aged 18 to 65 who meet specific criteria[1]. Eligible patients typically:

  • Have moderate-to-severe birch pollen allergies confirmed by skin prick tests and blood tests
  • Have experienced symptoms for at least two years
  • May have mild-to-moderate, well-controlled asthma (or no asthma)
  • Do not have severe allergies to other substances that might interfere with the study

It’s important to note that there are several exclusion criteria, such as previous birch pollen immunotherapy, severe asthma, and certain medical conditions[1].

Effectiveness

The effectiveness of BETULA VERRUCOSA (108) is currently being evaluated in clinical trials. Researchers are measuring its impact on allergy symptoms and medication use during birch pollen season. They are using a Combined Symptom and Medication Score (CSMS) to assess how well the treatment reduces allergy symptoms and the need for additional medications[1].

Other measures of effectiveness include:

  • Changes in quality of life
  • Number of symptom-free days
  • Responses to nasal provocation tests

Safety and Side Effects

As with any medical treatment, safety is a crucial consideration. The ongoing clinical trials are closely monitoring for any adverse reactions. Common side effects of sublingual immunotherapy can include mild oral itching or swelling, but more severe reactions are rare<a href="#1". The studies exclude individuals with a history of serious reactions to immunotherapy to minimize risks.

Ongoing Research

BETULA VERRUCOSA (108) is currently being studied in Phase II-III clinical trials[1]. These studies aim to determine the most effective and best-tolerated dose of the medication. Researchers are comparing different doses of the active treatment to a placebo to assess its efficacy and safety profile.

The results of these trials will help determine whether BETULA VERRUCOSA (108) could become an approved treatment option for individuals suffering from birch pollen allergies in the future.

Aspect Details
Study Type Phase II-III clinical trial
Treatment Sublingual immunotherapy with Betula Verrucosa (108) extract
Target Condition Moderate-to-severe allergic rhinitis/rhinoconjunctivitis due to birch pollen
Primary Endpoint Difference in Combined Symptom and Medication Score (CSMS) during Peak Birch Pollen Period
Key Inclusion Criteria Age 18-65, birch pollen allergy for at least 2 years, positive skin prick test and specific IgE to Betula verrucosa
Key Exclusion Criteria Recent immunotherapy, severe systemic reactions to immunotherapy, severe lung diseases, certain immune system disorders
Safety Assessments Monitoring of Treatment-Emergent Adverse Drug Reactions (TEADRs)

FAQ

  • What is Betula Verrucosa (108)? Betula Verrucosa (108) is a birch pollen extract used in allergy treatments. It's being studied as a potential sublingual immunotherapy for people with birch pollen allergies.
  • What is the main objective of the clinical trial using Betula Verrucosa (108)? The main objective is to determine the most effective and best-tolerated dose of SULGEN® Spray Betula verrucosa in terms of benefit-risk balance and Combined Symptom and Medication Score (CSMS).
  • Who can participate in this clinical trial? Participants must be between 18 and 65 years old, have moderate-to-severe allergic rhinitis or rhinoconjunctivitis due to birch pollen for at least two years, and meet specific criteria for birch pollen sensitization.
  • How is the effectiveness of the treatment measured? The primary measure of effectiveness is the difference in Combined Symptom and Medication Score (CSMS) during the Peak Birch Pollen Period between the treatment groups and the placebo group.
  • What are some of the exclusion criteria for the trial? Exclusion criteria include previous immunotherapy with birch pollen allergen extracts in the last 5 years, serious systemic reactions to allergen-specific immunotherapy in the past, severe or unstable lung diseases, and certain immune system disorders.

Ongoing Clinical Trials on Betula Verrucosa (108)

  • Short‑course sublingual ITULAZAX birch pollen extract with Lactobacillus rhamnosus GG for patients with pollen‑associated food allergy

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effectiveness and Safety of Phleum Pratense Pollen Extract for Patients with Moderate-to-Severe Grass Pollen Allergy

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effectiveness and Safety of Sublingual Immunotherapy with Betula Pendula Pollen Extract for Patients with Birch Pollen Allergy

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Allergic rhinitis: An allergic reaction affecting the nose, causing symptoms such as sneezing, itching, and runny nose, often triggered by specific allergens like pollen.
  • Rhinoconjunctivitis: A combination of rhinitis (nasal symptoms) and conjunctivitis (eye symptoms) often caused by allergies.
  • Sublingual immunotherapy: A form of allergy treatment where small doses of an allergen are placed under the tongue to help the body build tolerance over time.
  • Combined Symptom and Medication Score (CSMS): A measure used in allergy studies that combines the severity of allergy symptoms with the amount of medication needed for relief.
  • Peak Birch Pollen Period (PBPP): The time of year when birch pollen concentrations are at their highest levels in the air.
  • Forced expiratory volume (FEV1): A measure of lung function that represents the amount of air a person can forcefully exhale in one second.
  • Skin prick test: An allergy test where small amounts of allergens are pricked into the skin to check for allergic reactions.
  • Nasal provocation test: A test where allergens are applied to the nasal passages to diagnose or assess the severity of allergic rhinitis.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-sublingual-immunotherapy-with-betula-pendula-pollen-extract-for-patients-with-birch-pollen-allergy/