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Betula Pendula Pollen Extract

This article discusses a phase II-III clinical trial investigating the use of Betula Pendula Pollen Extract (birch pollen extract) in sublingual immunotherapy for patients with birch pollen allergy. The study aims to determine the most effective and best-tolerated dose of SULGEN® Spray Betula verrucosa for treating moderate-to-severe allergic rhinitis or rhinoconjunctivitis caused by birch pollen. The trial compares different doses of the medication to a placebo, evaluating both its effectiveness in reducing allergy symptoms and its safety profile.

Table of Contents

What is Betula Pendula Pollen Extract?

Betula Pendula Pollen Extract is a medical treatment derived from birch tree pollen. It is being studied as a potential therapy for people who suffer from allergies to birch pollen. This extract is classified as an allergen extract, which means it contains substances that can trigger allergic reactions in sensitive individuals[1].

Medical Condition Treated

The primary medical condition targeted by Betula Pendula Pollen Extract is moderate-to-severe allergic rhinitis or rhinoconjunctivitis caused by birch pollen. Allergic rhinitis is a condition where the inside of the nose becomes inflamed due to an allergic reaction, while rhinoconjunctivitis also involves inflammation of the eyes[1].

Symptoms of this condition may include:

  • Sneezing
  • Runny or stuffy nose
  • Itchy nose, eyes, or roof of the mouth
  • Red, watery eyes

How It Works

Betula Pendula Pollen Extract is used in a treatment called sublingual immunotherapy (SLIT). This therapy works by gradually exposing the immune system to small amounts of the allergen (in this case, birch pollen). Over time, this exposure can help the body build tolerance to the allergen, reducing allergic reactions when exposed to birch pollen in the environment[1].

Administration and Dosage

The medication is administered as a sublingual spray, which means it is sprayed under the tongue. The clinical trial is testing different doses of the medication, referred to as low, mid, and high doses. The maximum daily dose being tested is 0.2 ml, with a maximum total dose of 60.2 ml over a treatment period of 301 days[1].

Clinical Trial Details

A Phase II-III clinical trial is currently underway to assess the efficacy and safety of this treatment. The trial aims to determine the most effective and best-tolerated dose of the medication. The primary measure of effectiveness is the Combined Symptom and Medication Score (CSMS) during the peak birch pollen season[1].

Eligibility Criteria

To participate in the clinical trial, patients must meet certain criteria, including:

  • Age between 18 and 65 years
  • Diagnosed with moderate-to-severe allergic rhinitis or rhinoconjunctivitis due to birch pollen for at least two years
  • Confirmed sensitization to birch pollen through skin prick tests and blood tests
  • No previous immunotherapy with birch pollen allergen extracts in the last 5 years

Patients with severe asthma, certain immune system disorders, or other significant health conditions may not be eligible for the trial[1].

Potential Benefits

If proven effective, Betula Pendula Pollen Extract could offer several benefits for patients with birch pollen allergies:

  • Reduction in allergy symptoms during birch pollen season
  • Decreased need for allergy medications
  • Improved quality of life during allergy season
  • Potential long-term reduction in allergic sensitivity to birch pollen

Safety and Side Effects

As with any medical treatment, there may be potential side effects. The clinical trial is carefully monitoring the safety and tolerability of the treatment. Common side effects of sublingual immunotherapy may include mild itching or swelling in the mouth. Severe allergic reactions are rare but possible[1].

It’s important to note that this treatment is still under investigation, and its full safety profile and effectiveness have not yet been established. Patients should always consult with their healthcare provider before considering any new allergy treatments.

Aspect Details
Study Type Phase II-III clinical trial
Medication SULGEN® Spray Betula verrucosa (Betula Pendula Pollen Extract)
Administration Method Sublingual spray
Target Condition Moderate-to-severe allergic rhinitis/rhinoconjunctivitis due to birch pollen
Primary Outcome Difference in Combined Symptom and Medication Score (CSMS) during Peak Birch Pollen Period
Treatment Duration Up to 301 days
Participant Age Range 18-65 years
Key Inclusion Criteria Birch pollen allergy for at least 2 years, specific sensitization criteria
Key Exclusion Criteria Previous birch pollen immunotherapy, severe asthma, certain medical conditions

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this trial is to establish the most effective and best-tolerated dose of SULGEN® Spray Betula verrucosa for treating birch pollen allergy. The study aims to find the optimal balance between benefits and risks, as measured by the 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. They should have well-controlled mild-to-moderate asthma or no asthma at all.
  • What is sublingual immunotherapy? Sublingual immunotherapy is a treatment method where the medication, in this case, SULGEN® Spray Betula verrucosa, is administered under the tongue. This approach aims to gradually desensitize the immune system to birch pollen allergens, potentially reducing allergy symptoms over time.
  • How long does the treatment in this trial last? The maximum treatment period mentioned in the trial information is 301 days, which is approximately 10 months. This duration allows researchers to observe the effects of the treatment over an extended period, including through a birch pollen season.
  • What are the main outcomes being measured in this trial? The primary outcome is the difference in Combined Symptom and Medication Score (CSMS) during the Peak Birch Pollen Period between the active treatment groups and the placebo group. Secondary outcomes include changes in individual symptom scores, medication use, quality of life, and the response to nasal provocation tests.

Ongoing Clinical Trials on Betula Pendula Pollen Extract

  • 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, runny nose, and nasal congestion in response to allergens like pollen.
  • Rhinoconjunctivitis: A condition where both the nose and eyes are affected by an allergic reaction, causing symptoms in both areas.
  • Sublingual immunotherapy (SLIT): A form of allergy treatment where small amounts of an allergen are placed under the tongue to help the body build tolerance over time.
  • ARIA guideline: Allergic Rhinitis and its Impact on Asthma guideline, a set of recommendations for diagnosing and managing allergic rhinitis.
  • Combined Symptom and Medication Score (CSMS): A measure used to assess the effectiveness of allergy treatments by combining symptom severity scores with medication usage scores.
  • Peak Birch Pollen Period (PBPP): The time during birch pollen season when pollen counts are at their highest levels.
  • Birch Pollen Season (BPS): The entire period when birch trees release pollen, typically in spring.
  • Nasal Provocation Test (NPT): A diagnostic test where allergens are applied to the nasal mucosa to evaluate allergic reactions.
  • Visual Analogue Scale (VAS): A measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured.
  • Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ): A standardized survey used to measure the impact of rhinoconjunctivitis on a patient's quality of life.

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/