#1 Clinical Trials Search in Europe

Allergen Extract From Dactylis Glomerata Pollen, Glutaraldehyde-Modified

Recent clinical trials are investigating the use of a modified allergen extract from Dactylis Glomerata (orchard grass) pollen, along with other grass and tree pollen extracts, in the treatment of allergic rhinitis and asthma. These studies aim to assess the effectiveness and safety of subcutaneous immunotherapy using these allergen extracts in patients with moderate to severe allergic symptoms.

Table of Contents

What is Allergen Extract from Dactylis Glomerata Pollen, Glutaraldehyde-Modified?

Allergen Extract from Dactylis Glomerata Pollen, Glutaraldehyde-Modified is a specialized medication used in the treatment of grass pollen allergies. It is also known as Dactylis glomerata pollen polymerized extract[1]. This extract is part of a larger group of treatments called allergen extracts, which are used to desensitize the immune system to specific allergens.

How Does It Work?

This medication works through a process called immunotherapy. By exposing your body to small, controlled amounts of the allergen (in this case, modified grass pollen), your immune system gradually becomes less sensitive to it. The glutaraldehyde modification helps to make the allergen extract safer and more effective by altering its structure slightly[1].

What Medical Conditions Does It Treat?

The Allergen Extract from Dactylis Glomerata Pollen, Glutaraldehyde-Modified is used to treat several allergy-related conditions, including:

  • Allergic rhinitis: This is inflammation of the nasal passages caused by allergens, leading to symptoms like sneezing, runny nose, and nasal congestion.
  • Allergic rhinoconjunctivitis: This condition affects both the nasal passages and the eyes, causing symptoms in both areas.
  • Allergic asthma: Some patients with grass pollen allergies may also experience asthma symptoms, which this treatment can help manage[1].

How is It Administered?

The Allergen Extract from Dactylis Glomerata Pollen, Glutaraldehyde-Modified is administered as a subcutaneous injection. This means it’s injected just under the skin. The treatment is typically given over an extended period, often lasting several months to years, to achieve long-lasting desensitization[1].

Current Clinical Trials

Currently, this allergen extract is being studied in clinical trials to further evaluate its effectiveness and safety. These trials are focusing on patients with moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma[1].

Efficacy and Safety

The ongoing clinical trials aim to assess both the efficacy and safety of this treatment. Researchers are looking at various factors, 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 parameters (such as IgE and IgG4 levels)[1]

Who Can Use This Treatment?

This treatment is typically considered for individuals who:

  • Are between 12 and 65 years old
  • Have a confirmed history of grass pollen allergy
  • Show positive skin prick tests or blood tests for grass pollen allergens
  • Have moderate to severe allergic symptoms that are not well-controlled with standard medications[1]

Potential Side Effects

As with any medical treatment, there may be potential side effects. These can include:

  • Local reactions at the injection site (redness, swelling, itching)
  • Mild allergic reactions (sneezing, runny nose)
  • In rare cases, more severe allergic reactions

It’s important to note that this treatment is administered under medical supervision to monitor for and manage any potential side effects[1].

Aspect Details
Study Type Phase III clinical trials
Treatment Subcutaneous immunotherapy with modified allergen extracts including Dactylis Glomerata pollen
Target Conditions Moderate to severe allergic rhinitis/rhinoconjunctivitis, with or without mild to moderate asthma
Participant Age Range 12-65 years
Primary Outcome Overall symptom and medication scores during pollen seasons
Secondary Outcomes Symptom-free days, medication-free days, asthma exacerbations, quality of life, immunological parameters
Safety Monitoring Adverse events, administration site reactions, systemic reactions
Treatment Duration Up to 12 months
Maximum Daily Dose 0.5 ml

FAQ

  • What is the purpose of using Allergen Extract from Dactylis Glomerata Pollen in these clinical trials? The purpose is to evaluate the effectiveness and safety of this allergen extract, along with other grass and tree pollen extracts, in treating allergic rhinitis, rhinoconjunctivitis, and mild to moderate asthma through subcutaneous immunotherapy.
  • Who can participate in these clinical trials? Participants include individuals aged 12-65 with moderate to severe allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, who are sensitized to grass and specific tree pollens (either Juniperus oxycedrus or olive tree).
  • How is the treatment administered in these trials? The treatment is administered through subcutaneous injections of the allergen extracts, including the Dactylis Glomerata pollen extract, modified with glutaraldehyde.
  • 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, asthma exacerbations, quality of life, and immunological parameters such as specific IgE and IgG4 levels.
  • Are there any safety concerns being monitored in these trials? Yes, the trials are closely monitoring the safety of the immunotherapy, including any adverse events, administration site reactions, and systemic reactions. The overall rate, severity, and frequency of these events are being assessed.

Ongoing Clinical Trials on Allergen Extract From Dactylis Glomerata 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 diseases:
    Investigated drugs:
    Spain

Glossary

  • Allergen Extract: A solution containing proteins from substances that cause allergies, used in immunotherapy to help reduce allergic reactions over time.
  • Dactylis Glomerata: Also known as orchard grass, it is a common grass species whose pollen is a frequent cause of hay fever and allergic reactions.
  • 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 runny nose, sneezing, and congestion.
  • Rhinoconjunctivitis: A condition where both the nose and eyes are affected by allergic symptoms, including itching, redness, and watering.
  • 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 classify and guide the treatment of asthma.
  • Glutaraldehyde-Modified: A process applied to allergen extracts to change their structure, potentially making them more effective and safer for immunotherapy.
  • Specific IgE: Antibodies produced by the immune system in response to specific allergens, used to diagnose allergies.
  • Specific IgG4: A type of antibody that may increase during successful immunotherapy, potentially indicating developing tolerance to allergens.

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/