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Allergen Extract From Lolium Perenne Pollen, Glutaraldehyde-Modified

This article discusses clinical trials investigating the use of a modified allergen extract from Lolium Perenne (perennial ryegrass) pollen, along with other grass and tree pollen extracts, for treating allergic rhinitis, rhinoconjunctivitis, and mild asthma. These trials aim to assess the safety and efficacy of subcutaneous immunotherapy using these modified allergen extracts compared to placebo in patients with various allergic conditions.

Table of Contents

What is Allergen Extract from Lolium Perenne Pollen, Glutaraldehyde-Modified?

Allergen Extract from Lolium Perenne Pollen, Glutaraldehyde-Modified is a specialized medication used in the treatment of grass pollen allergies. It is part of a group of treatments known as allergen extracts.[1] This particular extract is derived from the pollen of Lolium Perenne, commonly known as perennial ryegrass, which is a widespread cause of grass allergies.

The extract is modified using glutaraldehyde, a chemical that alters the structure of the allergen. This modification process is designed to make the extract more effective and potentially safer for use in allergy treatments.[1]

How Does It Work?

This medication works through a process called immunotherapy. When administered to patients with grass pollen allergies, it helps the immune system become less sensitive to the allergen over time. By exposing the body to small, controlled amounts of the modified allergen, it can help reduce allergic reactions when the person is exposed to grass pollen in their environment.[1]

What Medical Conditions Does It Treat?

Allergen Extract from Lolium Perenne Pollen, Glutaraldehyde-Modified is primarily used to treat:

  • Allergic rhinitis (hay fever): This condition causes symptoms like sneezing, runny nose, and itchy eyes when exposed to allergens like grass pollen.
  • Allergic rhinoconjunctivitis: This involves both nasal symptoms and eye inflammation due to allergies.
  • Allergic asthma: Some patients with grass pollen allergies may also experience asthma symptoms, which this treatment can help manage.
The treatment is specifically designed for patients with moderate to severe symptoms that are either intermittent (occurring occasionally) or persistent (ongoing).[1]

How is It Administered?

This medication is administered through subcutaneous injection, which means it is injected just under the skin. The treatment is typically given as part of a long-term immunotherapy plan, often lasting several months to years. The maximum daily dose is usually 0.5 ml, with a maximum treatment period of 12 months.[1]

Current Clinical Trials

Currently, there are clinical trials underway to further evaluate the efficacy and safety of this treatment. These trials are focusing on patients with allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, who are sensitized to grass pollens.[1]

The trials are designed as prospective, multicentre, randomized, double-blind, and placebo-controlled studies. This means that participants are randomly assigned to receive either the active treatment or a placebo, and neither the patients nor the researchers know who is receiving which until the study is completed. This design helps ensure the results are as unbiased as possible.[1]

Efficacy and Safety

The main objective of the ongoing clinical trials is to evaluate the clinical efficacy of the allergen extract compared to a placebo. Researchers are looking at various factors, including:

  • Overall symptom and medication scores during the pollen season
  • Number of symptom-free days
  • Number of medication-free days
  • Frequency of asthma exacerbations
  • Quality of life improvements
The trials are also closely monitoring the safety of the treatment, including any adverse events that may occur.[1]

Potential Side Effects

As with any medical treatment, there is a potential for side effects. Common side effects of allergen immunotherapy can include:

  • Local reactions at the injection site (redness, swelling, itching)
  • Mild allergic reactions (sneezing, nasal congestion)
  • In rare cases, more severe allergic reactions
The ongoing clinical trials are carefully monitoring all adverse events to better understand the safety profile of this specific treatment.[1]

Who is Eligible for This Treatment?

While the final guidelines for patient eligibility will depend on the results of the clinical trials, current studies are including patients who meet the following criteria:

  • Ages 12 to 65 years
  • Diagnosed with moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate controlled asthma
  • Positive skin prick test to grass pollen extracts
  • Specific IgE antibodies to grass pollen
Patients with severe asthma, other significant health conditions, or a history of severe allergic reactions may not be eligible for this treatment.[1]

It’s important to note that this information is based on ongoing clinical trials, and the final approved use of the medication may differ. Always consult with a healthcare professional to determine if this treatment is appropriate for your specific situation.

Aspect Details
Study Type Phase III clinical trials
Design Prospective, multicentre, randomized, double-blind, placebo-controlled
Main Objective Evaluate efficacy and safety of subcutaneous immunotherapy with polymerized allergen extracts
Target Population Patients aged 12-65 with allergic rhinitis/rhinoconjunctivitis ± mild-moderate asthma
Allergens Studied Grass pollen mixture (including Lolium Perenne) + Juniperus oxycedrus or olive tree pollen
Primary Endpoint Overall symptom and medication score during relevant pollen seasons
Secondary Endpoints Symptom-free days, medication-free days, asthma exacerbations, quality of life, immunological parameters
Treatment Duration Up to 12 months
Administration Route Subcutaneous injection
Safety Assessment Monitoring of adverse events, including local and systemic reactions

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the clinical effectiveness and safety of subcutaneously administered polymerized allergen extracts compared to placebo in patients with allergic rhinitis, rhinoconjunctivitis, and mild to moderate asthma caused by grass and tree pollen allergies.
  • What types of patients are included in these trials? The trials include patients aged 12-65 years with moderate to severe intermittent or persistent allergic rhinitis or rhinoconjunctivitis, with or without controlled mild to moderate asthma, who are sensitized to grass and specific tree pollens (either Juniperus oxycedrus or olive tree).
  • How is the treatment administered in these trials? The treatment is administered subcutaneously as an immunotherapy, using a mixture of modified allergen extracts from various grass pollens (including Lolium Perenne) and either Juniperus oxycedrus or olive tree pollen.
  • What are the main outcomes being measured in these trials? The main outcomes include overall symptom and medication scores during pollen seasons, symptom-free days, medication-free days, asthma exacerbations, quality of life, immunological parameters, and safety of the immunotherapy.
  • How long do these clinical trials last? While the exact duration is not specified, the maximum treatment period mentioned is 12 months, suggesting that the trials last at least one year to cover a full pollen season.

Ongoing Clinical Trials on Allergen Extract From Lolium Perenne Pollen, Glutaraldehyde-Modified

  • Study on the Effectiveness and Safety of a Grass and Juniperus Oxycedrus Allergy Vaccine for Patients with Allergic Rhinitis or Rhinoconjunctivitis with or without Mild Asthma

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of a Grass and Olive Pollen Allergy Vaccine for Patients with Allergic Rhinitis or Asthma

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Allergen Extract: A solution containing proteins from substances that cause allergies, used in immunotherapy to help reduce allergic reactions over time.
  • Subcutaneous Immunotherapy: A treatment for allergies where small amounts of allergens are injected under the skin to help the body build tolerance to those allergens.
  • Rhinitis: Inflammation of the nasal passages, often causing symptoms like runny nose, sneezing, and congestion.
  • Rhinoconjunctivitis: A condition where both the nose and eyes are affected by allergy symptoms, including runny nose, sneezing, and itchy, watery eyes.
  • Polymerized: A process where allergen extracts are chemically modified to reduce their ability to cause immediate allergic reactions while maintaining their therapeutic effects.
  • Placebo: An inactive substance or treatment used in clinical trials as a control to compare against the effects of the actual medication being tested.
  • FEV1: Forced Expiratory Volume in 1 second, a measure of lung function used to assess the severity of asthma.
  • ARIA classification: Allergic Rhinitis and its Impact on Asthma, a system used to classify the severity and duration of allergic rhinitis symptoms.
  • GEMA 5.0: Spanish Guidelines for Asthma Management, version 5.0, used to classify and manage asthma in clinical practice.
  • Specific IgE: Antibodies produced by the immune system in response to specific allergens, measured to diagnose allergies.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-a-grass-and-juniperus-oxycedrus-allergy-vaccine-for-patients-with-allergic-rhinitis-or-rhinoconjunctivitis-with-or-without-mild-asthma/