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Dermatophagoides Farinae Allergoid, Glutaraldehyde-Modified

This article discusses clinical trials investigating the use of Clustoid MM09, a drug containing Dermatophagoides Farinae Allergoid and Dermatophagoides Pteronyssinus Allergoid, both glutaraldehyde-modified. These trials aim to assess the effectiveness and safety of this subcutaneous immunotherapy for patients suffering from allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by dust mite allergies.

Table of Contents

What is DERMATOPHAGOIDES FARINAE ALLERGOID, GLUTARALDEHYDE-MODIFIED?

DERMATOPHAGOIDES FARINAE ALLERGOID, GLUTARALDEHYDE-MODIFIED is a medical treatment used in allergen immunotherapy. It’s specifically designed to treat allergies caused by dust mites, particularly the species Dermatophagoides farinae[1]. This treatment is part of a medication called Clustoid MM09, which also includes a similar component for another common dust mite species, Dermatophagoides pteronyssinus.

Medical Conditions Treated

This treatment is used for patients with the following conditions:

  • Allergic rhinitis (inflammation of the nasal passages due to allergies)
  • Allergic rhinoconjunctivitis (inflammation affecting both the nasal passages and eyes)
  • Mild to moderate allergic asthma

These conditions are specifically related to dust mite allergies, which are classified as perennial allergies because they can occur year-round[1].

How It Works

DERMATOPHAGOIDES FARINAE ALLERGOID, GLUTARALDEHYDE-MODIFIED works through a process called immunotherapy. This treatment aims to reduce your body’s allergic response to dust mites over time. Here’s how it works:

  1. The treatment contains modified dust mite allergens.
  2. When administered, it exposes your immune system to small amounts of these allergens.
  3. Over time, your immune system becomes less sensitive to the allergens.
  4. This can lead to reduced allergic symptoms when you’re exposed to dust mites in your environment.

How It’s Administered

The treatment is given as a subcutaneous injection, which means it’s injected just under the skin[1]. 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 treatment should only be administered by healthcare professionals trained in managing potential allergic reactions.

Who Can Receive This Treatment?

This treatment is typically considered for patients who meet the following criteria:

  • Aged between 12 and 65 years old
  • Diagnosed with moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma
  • Confirmed allergy to Dermatophagoides farinae and/or Dermatophagoides pteronyssinus dust mites
  • Positive skin prick test results for these dust mites
  • Specific IgE (allergy antibody) levels above a certain threshold for these dust mites

However, there are also several conditions that might make a person ineligible for this treatment, such as severe asthma, certain autoimmune diseases, or pregnancy[1].

Effectiveness and Safety

The effectiveness and safety of this treatment are being studied in clinical trials. The main goal is to see if it can reduce allergy symptoms and the need for allergy medications compared to a placebo. Researchers are looking at various factors, including:

  • Changes in symptom scores for rhinitis, rhinoconjunctivitis, and asthma
  • Changes in medication use for these conditions
  • Quality of life improvements
  • Changes in immune system markers (like IgE and IgG4 antibodies)
  • Safety and occurrence of any side effects

The results of these studies will help determine how well this treatment works and how safe it is for long-term use[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, itchy eyes)

In rare cases, more severe allergic reactions can occur. This is why the treatment is only administered under medical supervision, and patients are typically observed for a short period after each injection[1].

Aspect Details
Drug Name Clustoid MM09
Active Substances Dermatophagoides Farinae Allergoid and Dermatophagoides Pteronyssinus Allergoid (glutaraldehyde-modified)
Administration Route Subcutaneous injection
Target Condition Moderate to severe allergic rhinitis/rhinoconjunctivitis with or without mild to moderate asthma
Age Range 12-65 years
Primary Objective Evaluate clinical efficacy compared to placebo
Secondary Objectives Assess safety, symptom scores, medication use, quality of life, immunological parameters
Trial Design Prospective, multicenter, randomized, double-blind, placebo-controlled
Treatment Duration Up to 12 months

FAQ

  • What is Clustoid MM09? Clustoid MM09 is a suspension for injection containing modified allergens from dust mites (Dermatophagoides Farinae and Dermatophagoides Pteronyssinus). It is being studied as a potential treatment for dust mite allergies.
  • Who can participate in these clinical trials? Participants must be between 12 and 65 years old, diagnosed with moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by dust mite allergies. They must meet specific criteria regarding skin prick tests and IgE levels.
  • How is the drug administered? Clustoid MM09 is administered subcutaneously, which means it is injected under the skin.
  • What are the main objectives of these trials? The main objective is to evaluate the clinical efficacy of Clustoid MM09 compared to a placebo in reducing allergy symptoms and medication use. The trials also aim to assess the safety of the treatment.
  • How long do the clinical trials last? The maximum treatment period mentioned in the trial information is 12 months.

Ongoing Clinical Trials on Dermatophagoides Farinae Allergoid, Glutaraldehyde-Modified

  • Clinical Trial of Dermatophagoides farinae, Dermatophagoides pteronyssinus, and Blomia tropicalis Allergen Extracts in Patients with Allergic Rhinitis/Rhinoconjunctivitis With or Without Mild Asthma

    Not yet recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Dermatophagoides farinae, Dermatophagoides pteronyssinus, and Lepidoglyphus destructor Immunotherapy for Allergic Rhinitis and Rhinoconjunctivitis in Patients With or Without Mild Asthma

    Not yet recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of Clustoid MM09 for Patients with Allergic Rhinitis or Rhinoconjunctivitis, with or without Mild to Moderate Asthma

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Allergic rhinitis: An allergic reaction affecting the nose, causing symptoms such as sneezing, runny nose, and nasal congestion.
  • Rhinoconjunctivitis: A combination of allergic rhinitis and conjunctivitis, affecting both the nose and eyes.
  • Dermatophagoides: A genus of house dust mites, common allergens that can trigger allergic reactions in sensitive individuals.
  • Allergoid: A modified form of an allergen that has reduced allergenicity but maintains its ability to stimulate the immune system.
  • Subcutaneous immunotherapy: A treatment method where allergens are injected under the skin to help the body build tolerance to specific allergens over time.
  • IgE (Immunoglobulin E): An antibody that plays a crucial role in allergic reactions. High levels of specific IgE indicate sensitivity to particular allergens.
  • 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, used to define and classify asthma severity and control.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-clustoid-mm09-for-patients-with-allergic-rhinitis-or-rhinoconjunctivitis-with-or-without-mild-to-moderate-asthma/