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Mixture Of Allergen Extracts Of Dermatophagoides Pteronyssinus And Dermatophagoides Farinae Polymerized With Glutaraldehyde

This article discusses a clinical trial investigating the effectiveness and safety of Beltavac®, a subcutaneous immunotherapy treatment for allergic rhinitis caused by house dust mites. The study aims to assess the drug’s efficacy in controlling symptoms, improving quality of life, and its overall safety profile in patients aged 12 to 65 with moderate to severe persistent rhinitis.

Table of Contents

What is BELTAVAC?

BELTAVAC is a medication used in subcutaneous immunotherapy for treating allergies caused by house dust mites. It contains a mixture of allergen extracts from two types of dust mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae. These extracts are polymerized with glutaraldehyde, which means they are chemically modified to improve their effectiveness and safety.[1]

How Does BELTAVAC Work?

BELTAVAC works by gradually exposing your immune system to small amounts of house dust mite allergens. Over time, this exposure helps your body build tolerance to these allergens, reducing allergic reactions. This type of treatment is known as immunotherapy, which aims to modify the underlying cause of the allergy rather than just treating the symptoms.[1]

Medical Conditions Treated

BELTAVAC is primarily used to treat:

  • Allergic rhinoconjunctivitis due to house dust mite exposure. This condition involves inflammation of the nose (rhinitis) and eyes (conjunctivitis) caused by an allergic reaction to dust mites.[1]
  • House dust mite allergy, which can cause various symptoms affecting the respiratory system and eyes.[1]

Clinical Trial Objectives

A clinical trial is being conducted to evaluate BELTAVAC’s effectiveness and safety. The main objectives of this trial include:

  1. Assessing the efficacy of BELTAVAC in treating allergic rhinitis caused by house dust mites over a 12-month period.[1]
  2. Evaluating its effectiveness in controlling rhinoconjunctivitis symptoms.[1]
  3. Measuring its overall impact on allergic symptoms.[1]
  4. Assessing the safety profile of the treatment.[1]
  5. Evaluating its effect on patients’ quality of life.[1]
  6. Measuring changes in specific immunoglobulin levels in the blood. Immunoglobulins are antibodies produced by the immune system in response to allergens.[1]
  7. Conducting an economic assessment of its clinical effects.[1]

Eligibility Criteria

To participate in the BELTAVAC clinical trial, patients must meet certain criteria. Some key inclusion criteria are:

  • Age between 12 and 65 years.[1]
  • Moderate to severe persistent rhinitis symptoms, with or without well-controlled asthma.[1]
  • Confirmed sensitization to house dust mites through skin prick tests and blood tests.[1]
  • A minimum score on a combined symptom and medication scale during a screening phase.[1]

Some exclusion criteria include:

  • Poorly controlled or severe asthma.[1]
  • Autoimmune diseases or immunodeficiency.[1]
  • History of severe allergic reactions (anaphylaxis) with heart or breathing problems.[1]
  • Recent use of certain medications that affect the immune system.[1]
  • Pregnancy or breastfeeding.[1]

Effectiveness Measures

The trial uses several measures to evaluate how well BELTAVAC works:

  • Combined Symptom and Medication Score (CSMS4): This score measures both the severity of allergy symptoms and the amount of medication needed to control them.[1]
  • Nasal Symptom Score (SS4): This focuses specifically on nasal allergy symptoms.[1]
  • Medication Score (MS): This measures the amount of allergy medication used.[1]
  • Nasal and Ocular Symptom Score (SS6): This includes both nasal and eye-related allergy symptoms.[1]
  • Combined Nasal, Ocular Symptom and Medication Score (CSMS6): This comprehensive score includes nasal symptoms, eye symptoms, and medication use.[1]
  • Percentage of days without symptoms or medication use.[1]

Administration and Dosage

BELTAVAC is administered as a subcutaneous injection, which means it’s injected under the skin. The maximum daily dose is 0.5 ml, and the treatment period can last up to 12 months. It’s important to note that this information is based on the clinical trial data, and the exact dosage and duration may vary depending on individual patient needs and responses to the treatment.[1]

Aspect Details
Study Drug Beltavac® (Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae polymerized with glutaraldehyde)
Administration Subcutaneous injection
Target Condition Allergic rhinitis/rhinoconjunctivitis due to house dust mites
Study Population Males and females aged 12-65 with moderate to severe persistent rhinitis
Primary Objective Assess efficacy of 12-month subcutaneous rush immunotherapy
Primary Endpoint Combined Symptom and Medication Score (CSMS4)
Secondary Objectives Assess efficacy in controlling symptoms, safety, quality of life impact, immunoglobulin levels, economic assessment
Treatment Duration 12 months
Maximum Daily Dose 0.5 ml

FAQ

  • What is Beltavac® and what is it used for? Beltavac® is a subcutaneous immunotherapy treatment containing a mixture of allergen extracts from house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae) polymerized with glutaraldehyde. It is used to treat allergic rhinitis or rhinoconjunctivitis caused by house dust mite allergies.
  • Who can participate in this clinical trial? The trial is open to males and females between 12 and 65 years of age with moderate or severe symptoms of persistent rhinitis. Participants must have a confirmed sensitization to house dust mites through a positive prick test and specific IgE levels.
  • What is the main objective of the study? The main objective is to assess the efficacy of subcutaneous rush immunotherapy with Beltavac® for 12 months in treating house dust mite-sensitized allergic rhinitis.
  • How is the effectiveness of Beltavac® measured in this trial? The primary measure of effectiveness is the Combined Symptom and Medication Score (CSMS4), which patients record daily in their online patient card over 4-week periods throughout the year-long follow-up.
  • Are there any exclusion criteria for the trial? Yes, some exclusion criteria include poorly controlled or severe asthma, autoimmune diseases, immunodeficiency, malignant neoplasms, severe cardiovascular diseases, and pregnancy or breastfeeding. Patients who have received immunotherapy for dust mite allergies in the past 5 years are also excluded.

Ongoing Clinical Trials on Mixture Of Allergen Extracts Of Dermatophagoides Pteronyssinus And Dermatophagoides Farinae Polymerized With Glutaraldehyde

  • Study on the Effectiveness and Safety of Beltavac for Patients with Allergic Rhinitis from House Dust Mites

    Recruiting

    1 1
    Investigated drugs:
    Spain

Glossary

  • Allergic rhinitis: An allergic reaction affecting the nasal passages, causing symptoms such as sneezing, runny nose, and congestion in response to allergens like house dust mites.
  • Subcutaneous immunotherapy: A treatment method where small amounts of allergens are injected under the skin to help the body build tolerance and reduce allergic reactions over time.
  • House dust mites: Tiny creatures that live in household dust and are a common cause of allergies, particularly species like Dermatophagoides pteronyssinus and Dermatophagoides farinae.
  • Polymerized allergenic extract: An allergy treatment where allergen proteins are chemically modified (polymerized) to reduce their ability to cause allergic reactions while maintaining their therapeutic effects.
  • Glutaraldehyde: A chemical used in the polymerization process of allergen extracts to modify their structure and reduce allergenicity.
  • Prick test: A skin test used to diagnose allergies by placing a small amount of allergen on the skin and pricking the surface to check for a reaction.
  • IgE (Immunoglobulin E): An antibody produced by the immune system in response to allergens, with high levels indicating an allergic sensitization.
  • CSMS4 (Combined Symptom and Medication Score): A scoring system used to evaluate the effectiveness of allergy treatments by combining symptom severity and medication use.
  • Rush immunotherapy: An accelerated form of immunotherapy where the initial dose escalation is completed more quickly than in conventional immunotherapy.
  • Rhinoconjunctivitis: A condition where both the nasal passages and eyes are affected by allergic symptoms, such as itching, redness, and tearing.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-beltavac-for-patients-with-allergic-rhinitis-from-house-dust-mites/