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Grass Pollen Allergen Extract Modified With Glutaraldehyde And Adsorbed To L-Tyrosine

This article discusses clinical trials investigating the use of Grass Pollen Allergen Extract Modified With Glutaraldehyde And Adsorbed To L-Tyrosine (PQ Grass) for treating seasonal allergic rhinitis in children and adolescents. The trials aim to evaluate the efficacy, safety, and long-term effects of this treatment for grass pollen-induced allergies.

Table of Contents

What is PQ Grass?

PQ Grass, also known as Pollinex Quattro Grass, is a medication designed to treat seasonal allergies caused by grass pollen[1]. It contains a special ingredient called grass pollen allergen extract that has been modified with a substance called glutaraldehyde and attached to another substance called L-tyrosine[1]. This unique formulation is meant to help your body become less sensitive to grass pollen over time.

Medical Conditions Treated

PQ Grass is specifically designed to treat seasonal allergic rhinitis and rhinoconjunctivitis caused by grass pollen[1]. These conditions are more commonly known as “hay fever” and typically cause symptoms such as:

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

These symptoms usually occur during the grass pollen season, which can vary depending on your location but is often in late spring and early summer.

How PQ Grass Works

PQ Grass works through a process called immunotherapy. This means it helps train your immune system to be less reactive to grass pollen[1]. By exposing your body to small, controlled amounts of modified grass pollen allergens, PQ Grass aims to reduce your allergic symptoms over time. The L-tyrosine in the formula helps to slow down the release of the allergen, potentially making the treatment more effective and reducing side effects.

Clinical Trial Overview

A long-term clinical trial is being conducted to test the effectiveness and safety of PQ Grass in children and adolescents[1]. This trial is divided into two parts:

  • Part A: A one-year study comparing PQ Grass to a placebo (a substance with no active medication)
  • Part B: A five-year extension study to evaluate the long-term effects of PQ Grass

The trial is “double-blind,” which means neither the participants nor the researchers know who is receiving PQ Grass and who is receiving the placebo during the study[1]. This helps ensure that the results are not influenced by expectations.

Eligibility Criteria

To participate in this clinical trial, children and adolescents must meet certain criteria[1]. Some key requirements include:

  • Age: 5 to 16 years old
  • History of moderate to severe seasonal allergic rhinitis due to grass pollen for at least one year
  • Positive skin prick test to grass pollen
  • Good general health

There are also several conditions that would prevent participation, such as severe asthma, certain autoimmune diseases, or allergies to other substances that might interfere with the study results[1].

Treatment Administration

PQ Grass is given as a subcutaneous injection, which means it’s injected just under the skin[1]. The treatment follows a specific schedule, starting with lower doses and gradually increasing to the full dose. This approach, known as dose escalation, helps reduce the risk of side effects.

Expected Benefits

The main goal of PQ Grass treatment is to reduce allergy symptoms during the grass pollen season. Researchers are measuring this using a Combined Symptom and Medication Score (CSMS)[1]. This score takes into account both how severe your symptoms are and how much allergy medication you need to use. The study is also looking at:

  • Improvement in quality of life
  • Changes in the immune system’s response to grass pollen
  • Long-term effectiveness of the treatment

Potential Side Effects

As with any medical treatment, PQ Grass may cause side effects. The clinical trial is carefully monitoring for any adverse events[1]. Common side effects of allergen immunotherapy can include:

  • Redness, swelling, or itching at the injection site
  • Mild allergy symptoms such as sneezing or itchy eyes
  • In rare cases, more severe allergic reactions

The study includes safety measures to minimize risks and handle any reactions that might occur.

Long-Term Effects

One of the key goals of this study is to understand the long-term effects of PQ Grass treatment[1]. Researchers are looking at whether the benefits of treatment continue even after stopping the medication. This could potentially mean long-lasting relief from grass pollen allergies.

The study is also monitoring for any long-term changes in the immune system, particularly levels of an antibody called IgG4, which may indicate a positive response to the treatment[1].

Aspect Details
Study Drug PQ Grass (Grass Pollen Allergen Extract Modified With Glutaraldehyde And Adsorbed To L-Tyrosine)
Target Condition Seasonal allergic rhinitis/rhinoconjunctivitis induced by grass pollen exposure
Study Population Children and adolescents aged 5-16 years
Study Design Long-term, double-blind, randomised, placebo-controlled clinical trial
Study Duration Part A: 1 year, Part B: 5 years
Primary Outcome Combined Symptom and Medication Score (CSMS) averaged over peak grass pollen season
Key Secondary Outcomes Long-term efficacy, quality of life, safety and tolerability
Dosing Subcutaneous injections, increasing from 900 to 6000 SU

FAQ

  • What is the purpose of these clinical trials? The trials aim to evaluate the effectiveness and safety of PQ Grass in treating seasonal allergic rhinitis caused by grass pollen in children and adolescents. They also seek to assess the long-term effects of the treatment.
  • Who can participate in these trials? Participants must be between 5 and 16 years old, have a history of moderate to severe seasonal allergic rhinitis due to grass pollen, and meet specific health criteria. They must also have positive skin prick tests and specific IgE levels to grass pollen.
  • How long do the trials last? The trials consist of two parts: Part A lasts for one year, while Part B is a long-term extension lasting five years. In total, participants may be involved for up to six years.
  • What is the main outcome being measured? The primary outcome is the Combined Symptom and Medication Score (CSMS) averaged over the peak grass pollen season. This measures the severity of allergy symptoms and the use of relief medications.
  • Are there any risks involved in participating? As with any clinical trial, there may be risks. The study monitors for adverse events, changes in laboratory values, and vital signs. Participants with severe asthma or other significant health conditions are excluded to minimize risks.

Ongoing Clinical Trials on Grass Pollen Allergen Extract Modified With Glutaraldehyde And Adsorbed To L-Tyrosine

  • Study on the Effectiveness of PQ Grass for Children and Teens with Seasonal Allergies from Grass Pollen

    Recruiting

    3 1 1
    Investigated drugs:
    Bulgaria Czechia Germany Lithuania Poland Romania +1

Glossary

  • Seasonal Allergic Rhinitis (SAR): A type of allergy that occurs at specific times of the year, typically caused by outdoor allergens like pollen. Symptoms include sneezing, runny nose, and itchy eyes.
  • PQ Grass: Short for 'Pollinex Quattro Grass', it's the grass pollen allergen extract modified with glutaraldehyde and adsorbed to L-tyrosine used in this study.
  • Combined Symptom and Medication Score (CSMS): A measure used to assess the severity of allergy symptoms and the use of relief medications in allergy studies.
  • Skin Prick Test (SPT): A method used to test for allergies by placing a small amount of an allergen on the skin and then pricking the skin to see if a reaction occurs.
  • IgE (Immunoglobulin E): An antibody that plays a crucial role in allergic reactions. High levels of specific IgE can indicate an allergy to a particular substance.
  • Rhinoconjunctivitis: A condition where both the nose and eyes are affected by allergy symptoms, causing sneezing, runny nose, and itchy, watery eyes.
  • Grass Pollen Season (GPS): The time of year when grass releases pollen into the air, typically causing allergy symptoms in sensitive individuals.
  • Forced Expiratory Volume (FEV1): A measure of lung function that represents the amount of air a person can forcefully exhale in one second.
  • Peak Expiratory Flow Rate (PEFR): The maximum rate of airflow that can be achieved when exhaling forcefully, used to assess lung function.
  • Standardised Unit (SU): A unit of measurement used to standardize the potency of allergen extracts in immunotherapy treatments.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-pq-grass-for-children-and-teens-with-seasonal-allergies-from-grass-pollen/