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Allergenic Extract Of Juniperus Oxycedrus Pollen Polymerized With Glutaraldehyde

This article discusses a clinical trial investigating the use of a drug containing Allergenic Extract of Juniperus Oxycedrus Pollen Polymerized with Glutaraldehyde, along with other grass pollen extracts, for treating allergic rhinitis and rhinoconjunctivitis. The study aims to assess the effectiveness and safety of this subcutaneous immunotherapy in patients with moderate to severe allergic symptoms, with or without mild asthma.

Table of Contents

What is ALLERGENIC EXTRACT OF JUNIPERUS OXYCEDRUS POLLEN POLYMERIZED WITH GLUTARALDEHYDE?

ALLERGENIC EXTRACT OF JUNIPERUS OXYCEDRUS POLLEN POLYMERIZED WITH GLUTARALDEHYDE is a specialized medication used in allergen immunotherapy. It is derived from the pollen of Juniperus oxycedrus, also known as the prickly juniper or cade juniper. This extract is chemically modified (polymerized) using glutaraldehyde to enhance its effectiveness and safety profile.[1]

This medication is part of a larger group of treatments called allergen extracts, which are used to desensitize the immune system to specific allergens. In this case, the treatment targets allergies related to Juniperus oxycedrus pollen.[1]

Medical Conditions Treated

This medication is primarily used to treat:[1]

  • Allergic rhinitis: An inflammation of the nasal passages caused by an allergic reaction, resulting in symptoms like sneezing, runny nose, and nasal congestion.
  • Allergic rhinoconjunctivitis: A condition that affects both the nose and eyes, causing symptoms in both areas due to an allergic reaction.
  • Mild to moderate allergic asthma: A type of asthma triggered by allergens, in this case, specifically related to Juniperus oxycedrus pollen.

The treatment is particularly focused on individuals with moderate to severe intermittent or persistent forms of these conditions.[1]

How It Works

This medication works through a process called immunotherapy. Here’s a simplified explanation of how it functions:[1]

  1. The allergenic extract contains small amounts of the allergen (Juniperus oxycedrus pollen).
  2. When administered to patients, it gradually exposes their immune system to the allergen.
  3. Over time, this exposure helps the immune system become less sensitive to the allergen.
  4. As a result, when the person encounters the allergen in their environment, their allergic reactions become less severe or may even stop altogether.

Current Clinical Trial

A clinical trial is currently underway to evaluate the effectiveness and safety of this treatment. The trial is described as a “Prospective, multicentre, randomized, double-blind, placebo-controlled, clinical trial”.[1]

Key aspects of the trial include:

  • It’s a Phase III clinical trial, which means it’s in an advanced stage of testing.
  • The treatment is being administered subcutaneously (under the skin).
  • It’s comparing the active treatment to a placebo to determine its effectiveness.
  • The trial is focusing on patients with rhinitis/rhinoconjunctivitis, with or without mild to moderate asthma.

Eligibility Criteria

The trial has specific criteria for who can participate. Some key inclusion criteria are:[1]

  • Ages 12 to 65 years
  • Confirmed history of allergy to grass and cupressaceae (cypress family) pollen
  • Positive skin prick test to the allergens
  • Specific IgE levels above 3.5 KU/L for the allergens

There are also several exclusion criteria, such as severe asthma, certain other medical conditions, and recent immunotherapy treatments.

Administration and Dosage

The medication is administered as a suspension for injection, given subcutaneously (under the skin). The maximum daily dose is 0.5 ml, with a maximum treatment period of 12 months.[1]

Potential Benefits

The clinical trial aims to assess several potential benefits, including:[1]

  • Reduction in overall symptoms and medication use during pollen seasons
  • Increase in symptom-free and medication-free days
  • Improvement in quality of life
  • Better control of asthma symptoms
  • Changes in immunological parameters (IgE and IgG4 levels)

Safety Considerations

As with any medical treatment, there are potential risks and safety considerations:[1]

  • The trial is closely monitoring for any adverse events, including local reactions at the injection site and systemic reactions.
  • Certain individuals, such as those with severe asthma, other significant health conditions, or pregnancy, are excluded from the trial due to potential risks.
  • The treatment is not recommended for individuals with certain autoimmune diseases, cancer, or immunodeficiencies.

It’s important to note that this treatment should only be administered under the supervision of a qualified healthcare professional, as they can properly assess individual risks and benefits.

Aspect Details
Study Type Phase III clinical trial: Prospective, multicentre, randomized, double-blind, placebo-controlled
Main Objective Evaluate clinical efficacy of subcutaneous polymerized allergen extracts vs placebo
Target Population Patients aged 12-65 with moderate-severe allergic rhinitis/rhinoconjunctivitis, with/without mild-moderate asthma
Investigational Drug Mixture of modified allergen extracts from 6 grasses and Juniperus oxycedrus pollen
Administration Subcutaneous injection, max daily dose 0.5 ml
Treatment Duration Up to 12 months
Primary Outcome Overall symptom and medication score during pollen season
Key Secondary Outcomes Symptom-free days, medication-free days, asthma exacerbations, quality of life

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to evaluate the clinical efficacy of subcutaneously administered polymerized allergen extracts compared to placebo in subjects with rhinitis/rhinoconjunctivitis, with or without controlled mild-moderate asthma.
  • Who can participate in this clinical trial? Participants should be between 12 and 65 years old, have a confirmed history of inhalation allergy to grass and cupressaceae, show positive skin prick tests to these allergens, and have specific IgE levels above 3.5 KU/L.
  • What is the drug being tested in this trial? The drug is a mixture of modified allergen extracts from 6 grasses and Juniperus oxycedrus pollen, polymerized with glutaraldehyde. It is administered as a suspension for injection.
  • How long does the treatment last? The maximum treatment period mentioned in the trial information is 12 months.
  • What are the main outcomes being measured in this trial? The primary outcome is the overall symptom and medication score during the pollen season. Secondary outcomes include symptom-free days, medication-free days, asthma exacerbations, quality of life, and safety of the immunotherapy.

Ongoing Clinical Trials on Allergenic Extract Of Juniperus Oxycedrus Pollen Polymerized With Glutaraldehyde

  • 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

Glossary

  • Allergenic Extract: A substance derived from a source of allergens (like pollen) used to diagnose or treat allergies.
  • Polymerized: A process where small molecules are chemically combined to form larger molecules, often used to modify allergens for immunotherapy.
  • Glutaraldehyde: A chemical used to modify allergens, making them more effective and safer for use in immunotherapy.
  • Subcutaneous Immunotherapy: A treatment for allergies where small amounts of allergens are injected under the skin to help the body build tolerance.
  • 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 allergic symptoms.
  • ARIA classification: Allergic Rhinitis and its Impact on Asthma, a system for classifying the severity and duration of allergic rhinitis symptoms.
  • FEV1: Forced Expiratory Volume in 1 second, a measure of lung function used to assess asthma severity.
  • Specific IgE: Antibodies produced by the immune system in response to specific allergens, measured to diagnose allergies.
  • Placebo: An inactive substance used as a control in clinical trials to compare with the effects of the actual drug being tested.

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/