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12 Grass Pollen Mixture

This article discusses a clinical trial investigating the effectiveness and safety of PQ Grass, a treatment for seasonal allergic rhinitis (hay fever) caused by grass pollen in children and adolescents. The study aims to evaluate both short-term and long-term effects of the treatment, as well as its safety profile, in patients aged 4 to 16 years old.

Table of Contents

What is PQ Grass?

PQ Grass is an investigational medication being studied for the treatment of seasonal allergic rhinitis (hay fever) and rhinoconjunctivitis (inflammation of the nose and eyes) caused by grass pollen in children and adolescents[1]. It is a form of allergen immunotherapy, which means it aims to help your body become less sensitive to grass pollen allergens over time.

Medical Condition Treated

PQ Grass is designed to treat seasonal allergic rhinitis and rhinoconjunctivitis specifically triggered by grass pollen exposure[1]. These conditions cause symptoms like sneezing, runny nose, itchy eyes, and congestion during grass pollen season, typically in spring and early summer.

How PQ Grass Works

PQ Grass works by exposing your immune system to small amounts of grass pollen allergens. Over time, this exposure can help your body build tolerance to these allergens, potentially reducing your allergic reactions when you encounter grass pollen in the environment[1].

Clinical Trial Overview

A long-term clinical trial is being conducted to investigate the effectiveness and safety of PQ Grass in children and adolescents[1]. The 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 long-term 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].

Eligibility Criteria

To participate in the trial, children and adolescents must meet certain criteria, including[1]:

  • 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
  • Elevated levels of grass-specific IgE (an antibody associated with allergies) in their blood

There are also several exclusion criteria, such as severe asthma, certain other medical conditions, or recent use of other allergy treatments[1].

Efficacy Measurements

The main way the researchers will measure how well PQ Grass works is by using a Combined Symptom and Medication Score (CSMS)[1]. This score takes into account both the severity of allergy symptoms and the amount of allergy medication needed during grass pollen season. Other measurements include:

  • Quality of life assessments
  • The number of “well days” and “severe days” during pollen season
  • Levels of grass-specific IgG4 (an antibody that may indicate developing tolerance to an allergen) in the blood

Safety Considerations

As with any medical treatment, safety is a crucial aspect of the PQ Grass clinical trial. The researchers will be monitoring[1]:

  • Frequency and severity of side effects
  • Any serious allergic reactions
  • Changes in laboratory test results, vital signs, and lung function tests

It’s important to note that PQ Grass is still an investigational treatment, and its full safety profile is not yet known. The clinical trial aims to provide more information about both its effectiveness and potential risks.

Aspect Details
Study Type Long-term, double-blind, randomized, placebo-controlled clinical trial
Medication PQ Grass 27600 SU
Target Population Children and adolescents aged 4-16 years with seasonal allergic rhinitis/rhinoconjunctivitis induced by grass pollen
Study Duration Part A: 1 year, Part B: 5 years
Primary Objectives Evaluate efficacy and long-term sustained efficacy of PQ Grass
Key Measurements Combined Symptom and Medication Score (CSMS), Total Combined Score (TCS), grass-specific IgG4 levels, quality of life
Safety Assessments Adverse events, clinical laboratory values, vital signs, spirometry/PEFR (for asthmatic subjects)

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the effectiveness and safety of PQ Grass 27600 SU in children and adolescents with seasonal allergic rhinitis or rhinoconjunctivitis caused by grass pollen exposure. The study aims to assess both short-term and long-term effects of the treatment.
  • Who can participate in this clinical trial? Participants must be between 4 and 16 years old, have a history of moderate to severe seasonal allergic rhinitis due to grass pollen for at least one year, and show positive skin prick test and specific IgE results for grass pollen. They must also be in good general health and able to perform certain breathing tests.
  • How long does the clinical trial last? The clinical trial consists of two parts: Part A lasts for 1 year and compares the efficacy and safety of the active treatment to a placebo. Part B is a long-term extension that lasts for 5 years, covering a total of five grass pollen seasons per participant.
  • What are the main outcomes being measured in this trial? The main outcomes being measured include the Combined Symptom and Medication Score (CSMS) during peak grass pollen season, changes in grass-specific IgG4 levels, quality of life assessments, and safety evaluations such as the frequency and severity of adverse events.
  • Is the trial blinded, and what does that mean? Yes, this is a double-blind clinical trial. This means that neither the participants, the investigators, nor other persons directly involved in conducting the trial (including the sponsor) will know whether a participant is receiving the active treatment or a placebo. This helps to prevent bias in the study results.

Ongoing Clinical Trials on 12 Grass Pollen Mixture

  • 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.
  • Rhinoconjunctivitis: A condition where both the nose and eyes are affected by allergy symptoms, causing inflammation in these areas.
  • PQ Grass: The investigational drug being tested in this clinical trial for the treatment of grass pollen allergies.
  • Placebo: A substance that looks like the real medicine but contains no active ingredient. It's used to compare the effects of the real treatment.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving the placebo.
  • 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.
  • IgG4 (Immunoglobulin G4): A type of antibody that may be associated with a protective effect against allergic reactions. Its levels are monitored in this study.
  • Skin Prick Test (SPT): A method used to diagnose allergies by applying a small amount of an allergen to the skin and observing the reaction.
  • Combined Symptom and Medication Score (CSMS): A measure used to assess the severity of allergy symptoms and the amount of medication needed to control them.
  • Grass Pollen Season (GPS): The time of year when grass pollen levels are highest, typically causing increased allergy symptoms in sensitive individuals.

References

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