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Allergen Extract From Phleum Pratense Pollen, Glutaraldehyde-Modified

This article discusses clinical trials investigating the use of Allergen Extract from Phleum Pratense Pollen, Glutaraldehyde-Modified, as part of a mixture with other grass and tree pollen extracts for treating allergic rhinitis and asthma. These trials aim to assess the safety and effectiveness of subcutaneous immunotherapy using these modified allergen extracts in patients with moderate to severe allergic symptoms.

Table of Contents

What is ALLERGEN EXTRACT FROM PHLEUM PRATENSE POLLEN, GLUTARALDEHYDE-MODIFIED?

ALLERGEN EXTRACT FROM PHLEUM PRATENSE POLLEN, GLUTARALDEHYDE-MODIFIED is a specialized allergy treatment derived from timothy grass (Phleum pratense) pollen. This extract is chemically modified using glutaraldehyde, a process that alters the structure of the allergens to make them less reactive while still maintaining their ability to stimulate the immune system[1].

How Does It Work?

This modified allergen extract works through a process called immunotherapy. By introducing small amounts of the modified allergen into your body over time, your immune system gradually becomes less sensitive to the actual grass pollen allergens. This can lead to reduced allergic reactions when you’re exposed to grass pollen in your environment[1].

Medical Conditions Treated

The primary conditions treated with this allergen extract include:

  • Allergic rhinitis (hay fever): Inflammation of the nasal passages causing symptoms like sneezing, runny nose, and nasal congestion
  • Allergic rhinoconjunctivitis: A combination of nasal and eye symptoms caused by allergies
  • Mild to moderate allergic asthma: Breathing difficulties triggered by allergens

These conditions can range from intermittent (occurring occasionally) to persistent (ongoing) and from moderate to severe in intensity[1].

How Is It Administered?

The allergen extract is administered as a subcutaneous injection, which means it’s injected just under the skin. Treatment typically involves a series of injections over time, with the dose gradually increasing to build up tolerance[1].

Current Clinical Trials

As of now, there are ongoing clinical trials to further evaluate the efficacy and safety of this treatment. These trials are focusing on its use in combination with other allergen extracts, such as those from olive tree pollen or Juniperus oxycedrus (prickly juniper) pollen[1][2].

Efficacy and Safety

The main objective of the current clinical trials is to assess how well this treatment works compared to a placebo in reducing allergy symptoms and medication use. Researchers are also closely monitoring its safety profile. The trials are measuring various outcomes, including:

  • Overall symptom and medication scores during pollen seasons
  • Number of symptom-free and medication-free days
  • Frequency of asthma exacerbations
  • Changes in quality of life
  • Changes in immunological markers (like IgE and IgG4 antibodies)

These measurements will help determine how effective the treatment is in real-world conditions[1][2].

Who Is Eligible for This Treatment?

While individual cases may vary, general eligibility criteria for this treatment include:

  • Age between 12 and 65 years
  • Confirmed history of grass pollen allergy
  • Positive skin prick test or specific IgE test for grass pollen
  • Moderate to severe allergy symptoms not adequately controlled by standard medications

It’s important to note that this treatment may not be suitable for everyone, particularly those with severe asthma, certain autoimmune conditions, or other specific health issues[1][2].

Potential Side Effects

As with any medical treatment, there can be side effects. Common reactions may include:

  • Local reactions at the injection site (redness, swelling, itching)
  • Mild allergic symptoms (sneezing, runny nose)

In rare cases, more severe allergic reactions can occur. That’s why this treatment is always administered under medical supervision, and patients are monitored after each injection[1][2].

Remember, if you think you might benefit from this treatment, it’s essential to discuss it with your allergist or healthcare provider. They can provide personalized advice based on your specific allergy profile and medical history.

Aspect Details
Study Type Phase III clinical trials
Design Prospective, multicentre, randomized, double-blind, placebo-controlled
Treatment Subcutaneous immunotherapy with polymerized allergen extracts
Allergens Grass pollen mixture (including Phleum pratense) with either Juniperus oxycedrus or Olea europaea
Target Population Patients aged 12-65 with moderate-severe allergic rhinitis/rhinoconjunctivitis, with or without mild-moderate asthma
Primary Outcome Overall symptom and medication scores during relevant pollen seasons
Secondary Outcomes Symptom-free days, medication-free days, quality of life, immunological parameters, safety assessments
Treatment Duration Up to 12 months
Maximum Dose 0.5 ml daily

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 moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma.
  • What allergens are included in the treatment being studied? The treatment includes a mixture of modified allergen extracts from various grass pollens (including Phleum pratense) and either Juniperus oxycedrus (cypress) or Olea europaea (olive) pollen, depending on the specific trial.
  • How is the treatment administered? The treatment is administered subcutaneously (as an injection under the skin).
  • Who can participate in these trials? Participants must be between 12 and 65 years old, have a confirmed history of allergic rhinitis or rhinoconjunctivitis (with or without mild-moderate asthma) caused by grass and either cypress or olive tree allergies, and meet specific criteria for allergy test results.
  • 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, quality of life measures, immunological parameters, and safety assessments of the immunotherapy.

Ongoing Clinical Trials on Allergen Extract From Phleum Pratense 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 drugs:
    Spain

  • Study of CLU-RX-PHL injection therapy for patients with moderate to severe grass pollen allergy to find the most effective and safe dose

    Not recruiting

    4 1
    Investigated drugs:
    Germany

Glossary

  • Allergen Extract: A solution containing proteins from substances that cause allergies, used to diagnose or treat allergic conditions.
  • Phleum Pratense: Also known as Timothy grass, a common type of grass that produces pollen that often causes allergies.
  • Glutaraldehyde-Modified: A process applied to allergen extracts to change their structure, potentially making them safer and more effective for immunotherapy.
  • Subcutaneous Immunotherapy: A treatment for allergies where small amounts of allergens are injected under the skin to help the body build tolerance over time.
  • Rhinitis: Inflammation of the nasal passages, often causing symptoms like sneezing, runny nose, and congestion.
  • Rhinoconjunctivitis: A condition where both the nose and eyes are affected by allergy symptoms.
  • ARIA Classification: Allergic Rhinitis and its Impact on Asthma, a system for classifying the severity and duration of allergic rhinitis symptoms.
  • GEMA 5.0: Spanish Guidelines for Asthma Management, version 5.0, used to classify asthma severity and control.
  • Polymerized Allergen Extracts: Allergen extracts that have been chemically modified to form larger molecules, potentially improving their effectiveness and safety in immunotherapy.
  • Placebo: An inactive substance used in clinical trials to compare the effects of a real treatment against no treatment.

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/
  2. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-a-grass-and-olive-pollen-allergy-vaccine-for-patients-with-allergic-rhinitis-or-asthma/