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Dactylis Glomerata Pollen Extract, Enriched

This article discusses a clinical trial investigating the use of Dactylis Glomerata Pollen Extract, Enriched, for diagnosing allergies. The study aims to determine the effectiveness of this extract in skin prick tests and assess its safety for patients with allergies to Dactylis glomerata (orchard grass) pollen.

Table of Contents

What is Dactylis Glomerata?

Dactylis glomerata, also known as orchard grass, is a common type of grass that can cause allergic reactions in some people. The pollen from this grass is a frequent trigger for allergies, particularly in areas where it grows abundantly[1].

Purpose of the Dactylis Glomerata Pollen Extract

The enriched Dactylis glomerata pollen extract is used as a diagnostic tool to identify allergies to this specific type of grass pollen. It’s not a treatment for allergies, but rather a means to confirm if a person is allergic to this particular grass[1].

This extract is used in a procedure called a skin prick test, which helps doctors diagnose allergies. The test can determine if a person has an allergy to Dactylis glomerata pollen, which can cause symptoms like rhinitis (inflammation of the nose lining, leading to sneezing and runny nose), rhinoconjunctivitis (inflammation affecting both the nose and eyes), and asthma (a condition affecting the airways, causing breathing difficulties)[1].

How the Diagnostic Test Works

The diagnostic test using Dactylis glomerata pollen extract is performed as follows:

  1. A small drop of the extract is placed on the skin, usually on the forearm or back.
  2. The skin is then gently pricked through the drop with a small, sterile probe.
  3. If the person is allergic to the pollen, a small, itchy bump (called a wheal) will appear at the site within about 15-20 minutes.
  4. The size of this wheal is measured and compared to the reaction produced by a control substance (usually histamine) to determine the severity of the allergy[1].

This test is known as a skin prick test or puncture test. It’s a quick and relatively painless way to diagnose allergies[1].

Who Can Use This Diagnostic Tool?

The Dactylis glomerata pollen extract test is designed for adults aged 18 to 64 who suspect they might have an allergy to this type of grass pollen. Specifically, it’s intended for people who:

  • Live in areas where Dactylis glomerata pollen is common
  • Have a history of allergy symptoms like hay fever or asthma during grass pollen season
  • Are not pregnant or breastfeeding
  • Are not taking certain medications that could interfere with the test results, such as antihistamines
  • Do not have certain skin conditions that could affect the test results[1]

Safety and Precautions

While the skin prick test is generally safe, there are some important precautions to consider:

  • The test should be performed by a healthcare professional trained in allergy testing.
  • People with certain health conditions, such as severe asthma or heart problems, may need special precautions.
  • There is a very small risk of a severe allergic reaction (anaphylaxis) during the test, which is why it’s performed in a medical setting where emergency treatment is available if needed.
  • Certain medications, especially antihistamines, need to be stopped before the test as they can interfere with the results[1].

Current Research and Development

Research is ongoing to improve the accuracy and safety of allergy diagnostic tests, including those for Dactylis glomerata pollen. A current clinical trial is studying how different concentrations of the pollen extract affect the skin’s reaction. This research aims to determine the optimal concentration that produces a reaction similar to a standard histamine solution, which could help standardize and improve the accuracy of these tests[1].

The study is also assessing the safety and tolerability of different concentrations of the extract. This information will help ensure that future tests are both effective and safe for patients[1].

Aspect Details
Trial Name 2024-514215-98-00
Drug Name Dactylis Glomerata Pollen Extract, Enriched
Trial Category Phase II Clinical Trial for allergy diagnosis
Main Objective Assess concentration of allergen extract inducing wheal equivalent to 10 mg/mL histamine dihydrochloride
Secondary Objective Evaluate safety and tolerability of the allergen extract
Participant Age Range 18 to 64 years
Key Inclusion Criteria Positive history of inhalant allergy, positive prick-test or specific IgE
Key Exclusion Criteria Recent immunotherapy, severe allergic reactions, certain medical conditions
Primary Endpoint Measurement of wheal area induced by allergen extract
Secondary Endpoints Adverse event rate, administration site reactions, systemic reactions
Maximum Daily Dose 2 drops
Maximum Treatment Period 1 day

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to determine the concentration of Dactylis glomerata pollen extract that produces a skin reaction equivalent to a standard histamine solution in allergy skin prick tests.
  • Who can participate in this clinical trial? Participants must be between 18 and 64 years old, have a history of inhalant allergy to Dactylis glomerata, and meet specific criteria regarding allergy tests and medical conditions.
  • What does the skin prick test involve? The skin prick test involves applying small amounts of the allergen extract to the skin and measuring the size of the resulting wheal (raised, itchy area) to determine the person's allergic reaction.
  • Are there any safety concerns for participants? The trial monitors for any adverse events, including administration site reactions and systemic reactions. Participants with certain medical conditions or taking specific medications are excluded for safety reasons.
  • How long does the treatment period last in this trial? The maximum treatment period for this trial is 1 day, as it primarily involves diagnostic testing rather than long-term treatment.

Ongoing Clinical Trials on Dactylis Glomerata Pollen Extract, Enriched

  • Study on Allergy to Phleum pratense and Dactylis glomerata: Testing Reactions to Phleum pratense and Dactylis glomerata Pollen Extracts in Patients with Allergies

    Not recruiting

    2 1 1
    Investigated drugs:
    Spain

Glossary

  • Dactylis Glomerata: Also known as orchard grass, it is a common grass species that produces pollen known to cause allergies in some people.
  • Allergen Extract: A solution containing specific allergens (substances that can cause allergic reactions) used for diagnostic testing or treatment of allergies.
  • Skin Prick Test: A method used to diagnose allergies by applying a small amount of an allergen to the skin and observing the reaction.
  • Wheal: A raised, itchy area on the skin that appears during an allergic reaction or skin prick test.
  • Histamine: A compound released by the body during allergic reactions, used as a positive control in allergy testing.
  • Rhinoconjunctivitis: A condition characterized by inflammation of the nose and eyes, often caused by allergies.
  • IgE: Immunoglobulin E, an antibody produced by the immune system in response to allergens.
  • Adverse Event (AE): Any unfavorable or unintended occurrence in a participant during a clinical trial, whether or not it is related to the treatment being studied.

References

  1. http://clinicaltrials.eu/trial/study-on-allergy-to-phleum-pratense-and-dactylis-glomerata-testing-reactions-to-phleum-pratense-and-dactylis-glomerata-pollen-extracts-in-patients-with-allergies/