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

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What is this study about?

This clinical trial focuses on treating patients with allergic rhinitis and rhinoconjunctivitis caused by birch pollen. These conditions cause symptoms like nasal congestion, runny nose, and eye irritation during birch pollen season. The study tests a medication called SLI-RX-BET, which is given as a spray under the tongue (sublingual spray) and contains birch pollen extract.

The purpose of this study is to find the most effective and safest dose of SLI-RX-BET for treating birch pollen allergies. The medication will be tested in three different strengths (low, medium, and high dose), and some participants will receive a placebo. The treatment involves daily use of the spray for approximately 10 months.

During the study, participants will need to track their allergy symptoms and use of additional medications during the birch pollen season. The treatment is specifically designed for people who have experienced moderate to severe allergic symptoms from birch pollen for at least two years. The medication aims to help reduce allergy symptoms and decrease the need for other allergy medications.

1 Initial treatment phase

You will begin treatment with a sublingual spray (medication applied under the tongue) containing either birch pollen extract or placebo

The spray will be one of three possible strengths: low dose, medium dose, or high dose of birch pollen extract, or a placebo solution without active substance

The spray should be used as directed under the tongue

2 Daily symptom recording

You will need to record your allergy symptoms daily in an electronic diary

The diary will track both nasal symptoms (affecting the nose) and eye symptoms

You will also need to record any additional allergy medications used for symptom relief

3 Quality of life assessment

You will complete a quality of life questionnaire about how allergies affect your daily activities

You will rate your overall discomfort from allergy symptoms on a scale from 0 to 10

4 Nasal testing

You will undergo a nasal provocation test where small amounts of birch pollen extract are applied to your nose

This test will be performed before and after the treatment period to measure any changes in your allergic response

5 Monitoring period

Your symptoms will be closely monitored during the birch pollen season

Special attention will be given during the peak birch pollen period

Any side effects or reactions to the treatment will be recorded

Who Can Join the Study?

  • Must sign and date the informed consent form before any study procedures begin
  • Must be between 18 and 65 years old when signing the consent form
  • Must have had moderate-to-severe allergic rhinitis (hay fever affecting nose and eyes) caused by birch pollen for at least 2 years. Patients can either have:
    – Well-controlled mild-to-moderate asthma, or
    – No asthma
  • For patients with asthma: Must have a lung function test (FEV1) showing breathing capacity greater than 70% of normal value
  • Must show confirmed allergy to birch pollen through:
    – Positive skin prick test (showing a raised bump of 3mm or larger)
    – Blood test showing specific antibodies to birch pollen
    – History of significant allergy symptoms during birch pollen season
    – Positive response to nasal testing with birch pollen extract
  • Must be able to understand and follow instructions from study staff
  • Must be able to complete an electronic diary to record symptoms and medication use
  • Must have laboratory test results within normal range or any abnormal results deemed not medically significant

Who Cannot Join the Study?

  • Previous participation in any clinical trial within the last 30 days
  • History of severe allergic reactions or anaphylaxis (life-threatening allergic reactions)
  • Current use of medications that could interfere with the study treatment
  • Pregnancy or breastfeeding
  • Serious heart, liver, or kidney disease
  • Active autoimmune diseases (conditions where the immune system attacks healthy body tissues)
  • Current cancer or history of cancer in the past 5 years
  • Severe asthma or poorly controlled asthma
  • History of substance abuse in the past 2 years
  • Mental health conditions that could affect study participation
  • Recent major surgery (within 3 months)
  • Active infections or fever
  • Known allergies to any components of the study medication
  • Use of immunosuppressive drugs (medications that weaken the immune system)
  • Chronic respiratory conditions other than allergic rhinitis

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Pmxieu fvs Hus uxh Ancbvhytqrkm Dni Yiuu Ypeqn Dresden Germany
Pkqouxinuzxf Akfuboltdzkq Pirrlo Dxf Tpqxes Ghxqp Bonn Germany
Hmc Phydrr Dpbkovl Dcw mepg Uyw Sudckmv Dresden Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
15.08.2025

Trial locations

Investigated drugs:

SLI-RX-BET is a sublingual immunotherapy treatment, which means it is administered under the tongue. It is designed to help patients who are allergic to birch pollen. This type of therapy works by gradually exposing the patient to small amounts of birch pollen allergen to help their immune system become less sensitive to it over time. The goal is to reduce allergic symptoms and the need for additional allergy medications when exposed to birch pollen.

This immunotherapy represents a more targeted approach to treating birch pollen allergies compared to traditional antihistamines or other allergy medications that only treat symptoms. Instead, it aims to modify the body’s immune response to the allergen itself.

Allergic rhinitis – A condition where the immune system reacts to airborne substances like pollen, causing inflammation of the nasal passages. It causes symptoms such as sneezing, runny nose, nasal congestion, and itchy nose. The condition often affects the eyes as well, leading to watery, itchy, and red eyes (rhinoconjunctivitis). When triggered by birch pollen specifically, symptoms typically occur during the birch tree pollination season. The condition is persistent and can significantly affect daily activities and sleep quality.

Rhinoconjunctivitis – A combination of rhinitis and conjunctivitis, where both the nasal passages and eyes are affected by an allergic reaction. The condition causes inflammation of the nasal membranes and the conjunctiva of the eyes. Symptoms include itchy, watery eyes, eye redness, along with nasal congestion, sneezing, and runny nose. The symptoms typically occur when exposed to specific allergens like pollen.

Trial ID:
2024-517520-19-00
Protocol code:
SL-3P2A
Trial Phase:
Therapeutic use (Phase IV)

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