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Phleum Pratense Pollen Extract

This article discusses a clinical trial investigating the use of Grastek®, a sublingual immunotherapy containing Phleum Pratense (Timothy grass) pollen extract, for treating allergic rhinoconjunctivitis. The study aims to evaluate the potential benefits of Grastek® in managing symptoms related to birch pollen allergies, even though it is primarily designed for grass pollen allergies. This pilot study involves a controlled environment and compares the effects of Grastek® to a placebo over a four-month treatment period.

Table of Contents

What is Grastek®?

Grastek® is a medication used to treat allergies caused by grass pollen. It contains an extract from Timothy grass (Phleum pratense) pollen, which is why it’s called a Phleum pratense pollen extract. This medication is a type of treatment known as sublingual immunotherapy (SLIT), which means it’s taken by placing a tablet under the tongue.[1]

How Grastek® Works

Grastek® works by gradually exposing your body to small amounts of grass pollen. Over time, this exposure helps your immune system become less sensitive to grass pollen, reducing your allergic reactions when you encounter it in the environment. This process is called desensitization.[1]

Conditions Treated by Grastek®

Grastek® is specifically designed to treat allergic rhinoconjunctivitis caused by grass pollen. This condition includes symptoms such as:[1]

  • Runny nose: Excessive nasal discharge
  • Itchy nose: An irritating sensation inside the nose
  • Sneezing: Sudden, forceful expulsion of air through the nose and mouth
  • Nasal congestion: A stuffy or blocked feeling in the nose
  • Eye symptoms: Such as itchy, watery, or red eyes

How Grastek® is Administered

Grastek® is taken as a tablet that dissolves under the tongue. In clinical studies, patients took one tablet daily for four months.[1] It’s important to follow your doctor’s instructions precisely when taking this medication.

Clinical Study on Grastek®

A clinical trial was conducted to evaluate the effectiveness of Grastek® in treating allergic rhinoconjunctivitis. This study, named NCT02394600, was designed as follows:[1]

  • Type of study: Phase IV, single center, placebo-controlled, parallel study
  • Number of participants: 96
  • Duration of treatment: 120 days (4 months)
  • Groups: Participants were divided into two groups:
    1. 48 participants received Grastek®
    2. 48 participants received a placebo (a sugar pill with no active ingredients)

Effectiveness of Grastek®

The main measure of effectiveness in the study was the change in Total Nasal Symptom Score (TNSS) from the beginning to the end of treatment. The TNSS measures four main symptoms of allergic rhinitis:[1]

  1. Runny nose
  2. Itchy nose
  3. Sneezing
  4. Nasal congestion

Each symptom is rated on a scale from 0 (no symptoms) to 3 (severe symptoms), resulting in a total score range of 0 to 12. A decrease in TNSS after treatment would indicate that Grastek® is effective in reducing allergy symptoms.

Potential Benefits of Grastek®

While the study primarily focused on grass pollen allergies, researchers were also interested in whether Grastek® might have benefits for people with birch pollen allergies. This suggests that Grastek® might potentially help with multiple types of pollen allergies, though more research is needed to confirm this.[1]

Additionally, the study aimed to identify potential biomarkers that could predict how well a person might respond to Grastek® treatment. Biomarkers are measurable indicators in the body (often found in blood samples) that can provide information about a person’s health or response to treatment.[1]

Aspect Details
Study Type Phase IV, single center, placebo-controlled, parallel design
Medication Grastek® (Phleum Pratense Pollen Extract)
Condition Allergic Rhinoconjunctivitis (focusing on birch pollen-induced)
Participants 96 (48 receiving Grastek®, 48 receiving placebo)
Treatment Duration 120 days (4 months)
Dosage One tablet daily (2800 BAU of Timothy grass extract)
Primary Outcome Change in Total Nasal Symptom Score (TNSS)
Secondary Outcome Analysis of blood samples for potential biomarkers
Study Environment Environmental Exposure Unit (EEU) for controlled pollen exposure

FAQ

  • What is Grastek® and what is it used for? Grastek® is a standardized sublingual immunotherapy tablet containing Phleum Pratense (Timothy grass) pollen extract. It is approved for treating grass pollen-induced allergic rhinoconjunctivitis in Canada and the United States.
  • What is the main goal of this clinical trial? The main goal is to determine if Grastek®, which is designed for grass pollen allergies, can also provide benefits for people with birch pollen-induced allergic rhinoconjunctivitis.
  • How long does the treatment last in this study? The treatment in this study lasts for 120 days (four months), with participants taking one tablet daily of either Grastek® or a placebo.
  • What is the Environmental Exposure Unit (EEU) mentioned in the study? The Environmental Exposure Unit (EEU) is a closed environment where participants are exposed to a controlled, constant level of airborne pollen. This allows researchers to study allergic reactions under standardized conditions.
  • How is the effectiveness of Grastek® measured in this trial? The primary measure of effectiveness is the change in Total Nasal Symptom Score (TNSS) from baseline to post-treatment. TNSS evaluates four symptoms: runny nose, itchy nose, sneezing, and nasal congestion on a scale from 0 to 12.

Ongoing Clinical Trials on Phleum Pratense Pollen Extract

  • Study of Grass Pollen Extract and Olive Pollen Extract for Patients with Hay Fever and Asthma caused by Grass and Olive Pollen Allergies

    Not yet recruiting

    3 1
    Investigated drugs:
    Portugal Spain

  • Study of the efficacy and safety of depigmented polymerized grass pollen extracts for patients with allergic rhinitis and controlled asthma.

    Not yet recruiting

    3 1
    Investigated drugs:
    Portugal Spain

  • Study of sublingual immunotherapy with Phleum pratense pollen extract spray in patients with moderate to severe grass pollen allergic rhinitis

    Not recruiting

    4 1
    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

Glossary

  • Allergic Rhinoconjunctivitis: A condition characterized by inflammation of the nasal passages and eyes due to an allergic reaction, typically causing symptoms such as sneezing, runny nose, itchy eyes, and congestion.
  • Sublingual Immunotherapy (SLIT): A form of allergy treatment where small amounts of allergens are placed under the tongue to help the body build tolerance over time.
  • Phleum Pratense: The scientific name for Timothy grass, a common cause of grass pollen allergies and the source of the extract used in Grastek®.
  • BAU (Bioequivalent Allergy Units): A standardized measure of allergen potency used in immunotherapy products.
  • Placebo: An inactive substance or treatment used in clinical trials as a control to compare against the effects of the actual medication being studied.
  • Total Nasal Symptom Score (TNSS): A measure used to assess the severity of nasal allergy symptoms, including runny nose, itchy nose, sneezing, and nasal congestion.
  • Biomarkers: Measurable indicators in the body that can be used to predict or monitor the effects of a treatment or the progression of a condition.

References

  1. https://clinicaltrials.gov/study/NCT02394600