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

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a treatment for people who have been suffering from moderate-to-severe allergic rhinitis or rhinoconjunctivitis due to grass pollen for at least two years. The treatment being tested is called SULGEN® Spray Phleum pratense, which is a type of sublingual immunotherapy. This means the treatment is administered as a spray under the tongue. The study aims to find the most effective and well-tolerated dose of this spray, balancing its benefits and risks.

Participants in the study will receive either the SULGEN® Spray Phleum pratense or a placebo, which looks and tastes like the real treatment but does not contain the active ingredient. The study will compare the effects of the treatment and the placebo on symptoms and the need for additional medication during the peak grass pollen period. The study will also look at how the treatment affects the quality of life and the number of days participants experience no symptoms or severe symptoms.

The trial will involve regular assessments to monitor the participants’ symptoms and any changes in their condition. This includes using a nasal provocation test, which involves exposing the nose to the allergen to see how it reacts. The study is expected to run until October 2025, with recruitment starting in November 2023. The goal is to provide valuable information on how well the SULGEN® Spray Phleum pratense works for people with grass pollen allergies.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a skin prick test using solutions such as timothy grass pollen extract and phleum pratense pollen extract to verify sensitization.

A positive skin prick test is indicated by a wheal diameter of at least 3 mm, with a negative control less than 2 mm and a positive histamine control of at least 3 mm.

2 baseline evaluation

A baseline evaluation is performed to record initial symptoms and medication use. This involves completing an electronic diary for self-evaluation of symptoms and rescue medication.

3 treatment phase

The treatment phase involves the administration of SULGEN® Spray Phleum pratense in varying doses. The spray is used sublingually, meaning it is applied under the tongue.

The dosage is adjusted to determine the most effective and best-tolerated dose. The treatment aims to improve the Combined Symptom and Medication Score (CSMS) during the peak grass pollen period.

4 monitoring and evaluation

Throughout the trial, symptoms and medication use are monitored using the electronic diary. This helps assess the efficacy of the treatment compared to a placebo.

Regular assessments are conducted to evaluate changes in symptoms and quality of life using tools like the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Visual Analogue Scale (VAS).

5 final assessment

At the end of the trial, a final assessment is conducted to compare pre-treatment and post-treatment results.

The primary endpoint is the difference in mean CSMS during the peak grass pollen period between the active treatment and placebo groups.

Who Can Join the Study?

  • Patients must have signed and dated the informed consent form before any study-specific examination.
  • Participants can be female or male and must be between 18 and 65 years old at the time of signing the informed consent form.
  • Patients should have had moderate-to-severe allergic rhinitis/rhinoconjunctivitis due to grass pollen for at least two years. This condition involves symptoms like a runny or blocked nose and itchy or watery eyes.
  • Patients can have mild-to-moderate asthma that is well-controlled, or they can have no asthma at all. Asthma is a condition that affects the airways in the lungs, making it hard to breathe.
  • For patients with asthma, their forced expiratory volume (FEV1) in one second should be more than 70% of the predicted normal value. FEV1 is a measure of how much air a person can forcefully exhale in one second.
  • Patients must be sensitized to Phleum pratense pollen, which means they have an allergic reaction to this type of grass pollen. This is confirmed by:
    • A positive skin prick test, which involves placing a small amount of allergen on the skin and pricking it to see if there is a reaction.
    • A blood test showing a certain level of IgE antibodies specific to Phleum pratense. IgE antibodies are proteins made by the immune system in response to allergens.
    • A Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) of 2 or more, based on the most severe days during one of the two grass pollen seasons before joining the study. This score measures the severity of symptoms like sneezing and itchy eyes.
    • A positive response to a nasal provocation test with Phleum pratense pollen allergen extract, which involves exposing the nose to the allergen to see if symptoms occur.
  • Patients must be able to understand and use an electronic diary to record their symptoms and any medication they take.
  • Patients must have safety laboratory results that are within the normal range or not considered clinically significant.

Who Cannot Join the Study?

  • Patients who have not experienced moderate-to-severe allergic rhinitis or rhinoconjunctivitis due to grass pollen for at least two years. Allergic rhinitis is a condition where your nose gets stuffy or runny due to allergies. Rhinoconjunctivitis is when both your nose and eyes are affected by allergies.
  • Patients who do not fit the age range specified for the study.
  • Patients who are not willing or able to follow the study procedures.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are taking medications that could affect the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of severe reactions to similar treatments.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have any other reason that the study doctors believe would make it unsafe or inappropriate for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Paevamufnodn Ajhubqhnxocy Pxfizr Dya Tkvirg Gtluc Bonn Germany
Pmxunh Dfw Wretoyhe Fohwubdae Hamburg 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 recruiting
06.11.2023

Trial locations

Investigated drugs:

SULGEN® Spray Phleum pratense is a sublingual immunotherapy treatment being tested for its effectiveness and safety in patients with grass pollen allergy. This therapy involves administering a spray under the tongue, which contains extracts from the grass species Phleum pratense, commonly known as Timothy grass. The goal of this treatment is to help the immune system become less sensitive to grass pollen, thereby reducing allergy symptoms and the need for other allergy medications. The trial aims to find the most effective dose that provides the best balance between benefits and potential side effects.

Investigated diseases:

Allergic Rhinitis – Allergic rhinitis is a condition characterized by inflammation of the nasal passages due to an allergic reaction, often triggered by pollen, dust, or pet dander. Symptoms include sneezing, nasal congestion, runny nose, and itchy eyes. It can be seasonal, occurring at certain times of the year, or perennial, occurring year-round. The condition is often associated with other allergic disorders, such as asthma or eczema. Over time, symptoms may vary in intensity and can affect daily activities and sleep.

Trial ID:
2023-505880-35-00
Trial Phase:
Therapeutic use (Phase IV)

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