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Allergenic Extract Of Grass Pollen Mixture: Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense And Poa Pratensis (1:1:1:1:1), Polymerised

This article discusses a clinical trial investigating the effectiveness of Beltavac® with a polymerized extract of grass pollen mixture for treating allergic rhinoconjunctivitis, with or without asthma. The study aims to determine the optimal therapeutic dose of the medication administered in a rush regimen, focusing on its impact on symptoms and medication use during pollen season.

Table of Contents

What is Beltavac?

Beltavac is an innovative immunotherapy treatment designed to help patients suffering from grass pollen allergies[1]. It contains a polymerized extract of grass pollen mixture, which includes five common grass species: Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, and Poa pratensis. These grasses are often responsible for triggering allergic reactions in many individuals during the pollen season.

How Does Beltavac Work?

Beltavac works by gradually exposing your immune system to small amounts of grass pollen allergens. This exposure helps your body build tolerance to these allergens over time, reducing your allergic reactions when you encounter grass pollen in your environment[1]. The polymerized form of the allergen extract in Beltavac means that the allergens have been chemically modified to make them safer and more effective for immunotherapy.

Medical Conditions Treated

Beltavac is specifically designed to treat:

  • Allergic rhinoconjunctivitis: This condition involves inflammation of the nose and eyes due to an allergic reaction. Symptoms may include sneezing, runny nose, itchy or watery eyes, and nasal congestion[1].
  • Seasonal allergy: Also known as hay fever, this refers to allergic symptoms that occur during specific times of the year, typically when certain plants pollinate[1].
  • Allergic asthma: Some patients with grass pollen allergies may also experience asthma symptoms. Beltavac may help control these symptoms when they’re associated with grass pollen allergy[1].

Administration and Dosage

Beltavac is administered as a subcutaneous injection, which means it’s injected just under the skin. The treatment follows a specific schedule[1]:

  1. Initial dose: 0.2 ml in one arm and 0.3 ml in the other arm, given 30 minutes apart.
  2. Subsequent doses: A single injection of 0.5 ml per month for 5 months.

This schedule is designed to build up your tolerance gradually and safely. The entire treatment course typically lasts for about 24 weeks[1].

Effectiveness

The effectiveness of Beltavac is being studied in clinical trials. Researchers are looking at several factors to determine how well it works[1]:

  • Reduction in sensitivity to grass pollen, as measured by a Conjunctival Provocation Test (CPT).
  • Improvement in nasal and eye symptoms during the peak pollen season.
  • Reduction in the need for allergy medications during the pollen season.

Who Can Use Beltavac?

Beltavac is intended for adults aged 18 to 65 who have a confirmed grass pollen allergy. To be eligible for this treatment, patients typically need to meet several criteria[1]:

  • A history of moderate to severe allergic rhinoconjunctivitis due to grass pollen for at least two pollen seasons.
  • Positive skin prick test and blood test results for grass pollen allergens.
  • Good overall health, with normal liver and kidney function.

Patients with controlled asthma may also be eligible for Beltavac treatment[1].

Potential Side Effects and Precautions

As with any medical treatment, Beltavac may cause side effects. While specific side effects are not detailed in the provided information, patients should be aware that allergic reactions are possible with any immunotherapy treatment. It’s crucial to discuss potential risks and side effects with your healthcare provider[1].

Certain individuals should not use Beltavac, including[1]:

  • Those with a history of severe allergic reactions or anaphylaxis.
  • Patients with uncontrolled asthma or other serious respiratory conditions.
  • Individuals with certain autoimmune diseases or immune deficiencies.
  • Pregnant or breastfeeding women.

Always consult with your doctor to determine if Beltavac is suitable for you based on your individual health status and medical history.

Aspect Details
Study Type Randomized, double-blind, placebo-controlled clinical trial
Medication Beltavac® with polymerized extract of grass pollen mixture
Condition Allergic rhinoconjunctivitis (with or without asthma)
Main Objective Establish optimal therapeutic dose
Secondary Objective Assess impact on symptoms and medication use during pollen season
Treatment Groups 1) Beltavac® 2RC/ml, 2) Beltavac® 5RC/ml, 3) Placebo
Administration Rush regimen followed by monthly injections
Primary Endpoint Change in reactivity to Conjunctival Provocation Test
Secondary Endpoints Symptom scores, medication use during peak pollen season

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to establish the optimal therapeutic dose of Beltavac® with a polymerized extract of grass pollen mixture for treating allergic rhinoconjunctivitis. The study also aims to assess how the treatment affects symptoms and medication use during pollen season.
  • Who can participate in this clinical trial? Participants must be between 18 and 65 years old, have a confirmed diagnosis of grass pollen allergy, and have experienced moderate to severe rhinitis for at least the previous two pollen seasons. They must also have positive skin prick tests and specific IgE levels to grass pollen allergens. Some participants may have controlled asthma.
  • How is the medication administered in this trial? The medication is administered following a rush administration schedule. Initially, 0.2 ml is given in one arm and 0.3 ml in the other arm, 30 minutes later. Subsequently, participants receive a single injection of 0.5 ml per month for 5 months.
  • What are the different treatment groups in this study? Participants are randomly assigned to one of three groups: 1) Beltavac® with polymerized extract of grass pollen mixture at 2RC/ml, 2) Beltavac® with polymerized extract of grass pollen mixture at 5RC/ml, or 3) a placebo vaccine.
  • How will the effectiveness of the treatment be measured? The primary measure of effectiveness is the proportion of patients whose reactivity to the Conjunctival Provocation Test (CPT) with grass extract decreases between baseline and visit 7. Secondary measures include combined nasal and conjunctival symptoms scores, rescue medication use, and daily medication scores during the peak pollen season, recorded through a patient diary app.

Ongoing Clinical Trials on Allergenic Extract Of Grass Pollen Mixture: Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense And Poa Pratensis (1:1:1:1:1), Polymerised

  • Study to Find the Best Dose of Beltavac with Grass Pollen Extract for Patients with Allergic Rhinoconjunctivitis, with or without Asthma

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Poland Spain

  • Study on the Effectiveness of Beltavac with Grass Pollen Extract for Patients with Allergic Rhinoconjunctivitis and Possible Asthma

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Poland Spain

Glossary

  • Allergic rhinoconjunctivitis: A condition characterized by inflammation of the nose and eyes due to an allergic reaction, typically causing symptoms such as sneezing, runny nose, itchy eyes, and congestion.
  • Polymerized extract: A modified form of an allergen extract where the allergen molecules are chemically linked together, potentially reducing allergenicity while maintaining immunogenicity.
  • Rush regimen: An accelerated schedule for administering immunotherapy, where the initial doses are given more frequently than in conventional immunotherapy schedules.
  • Conjunctival Provocation Test (CPT): A diagnostic test used to assess eye allergies by applying increasing concentrations of an allergen to the eye and observing the allergic response.
  • Specific IgE: Antibodies produced by the immune system in response to specific allergens. High levels of specific IgE indicate sensitization to that particular allergen.
  • Skin prick test: A method used to diagnose allergies by placing a small amount of a suspected allergen on the skin and then pricking the skin to allow the substance to enter. A positive reaction typically appears as a raised, itchy bump.
  • FEV1: Forced Expiratory Volume in 1 second, a measure of lung function used to assess the severity of airflow obstruction in conditions like asthma.
  • Peak Expiratory Flow (PEF): The maximum rate of airflow achieved when exhaling forcefully, used to monitor lung function and assess the severity of asthma.
  • ARIA: Allergic Rhinitis and its Impact on Asthma, a guideline for classifying the severity of allergic rhinitis.
  • GINA: Global Initiative for Asthma, an organization that provides guidelines for asthma management and prevention.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-beltavac-with-grass-pollen-extract-for-patients-with-allergic-rhinoconjunctivitis-and-possible-asthma/