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Phleum Pratense Pollen Extract, Enriched

This article discusses a clinical trial investigating the use of Phleum Pratense Pollen Extract, Enriched, for diagnosing allergies to Phleum pratense (Timothy grass) and Dactylis glomerata (Orchard grass). The study aims to determine the optimal concentration of the allergen extract that produces a skin reaction equivalent to a standard histamine solution, as well as assess its safety and tolerability.

Table of Contents

What is Phleum Pratense?

Phleum pratense, commonly known as Timothy grass, is a type of grass that produces pollen known to cause allergic reactions in many people. This grass is widespread in many parts of the world, making it a significant source of allergies.[1]

About the Medication

The medication being studied is called “Prick test of enriched Phleum pratense pollen extract.” It’s a solution used for a skin-prick test, which is a method to diagnose allergies. This product contains an extract from Phleum pratense pollen, which has been enriched to enhance its effectiveness in detecting allergies.[1]

Key points about this medication:

  • It’s manufactured by INMUNOTEK S.L.
  • It’s classified under “Tests for Allergic Diseases” in medical categorization
  • It’s not an oral medication, but a solution applied to the skin during allergy testing
  • The maximum daily dose is 2 drops, with a total maximum dose of 6 nanoliters

Medical Conditions Treated

This medication is specifically designed to diagnose allergies to Phleum pratense (Timothy grass) and Dactylis glomerata (Orchard grass). These grasses are common causes of hay fever and other allergic reactions, particularly in areas where these grasses are prevalent.[1]

Symptoms of grass pollen allergy may include:

  • Sneezing
  • Runny or stuffy nose
  • Itchy eyes, nose, and throat
  • Watery eyes
  • In some cases, asthma symptoms

How the Test Works

The skin-prick test using this solution helps diagnose allergies by observing the skin’s reaction. Here’s how it works:[1]

  1. A small amount of the allergen extract is placed on the skin, usually on the forearm or back.
  2. The skin is then pricked with a small, sterile probe to allow the solution to enter just below the skin’s surface.
  3. If you’re allergic to the substance, a small, raised, red, and itchy bump (called a wheal) will appear at the site within about 15-20 minutes.
  4. The size of the wheal is measured to determine the severity of the allergy.

Eligibility for the Test

Not everyone is eligible for this allergy test. Here are some key eligibility criteria:[1]

  • Age: Must be between 18 and 64 years old
  • Location: Should live in an area where Phleum pratense and Dactylis glomerata allergies are common
  • Medical history: Should have a history of inhalant allergy (such as rhinitis, rhinoconjunctivitis, or asthma) to these grasses
  • Previous tests: Should have had a positive prick test or presence of specific IgE antibodies to these allergens

Safety Considerations

While the skin-prick test is generally safe, there are some important safety considerations:[1]

  • The test is not suitable for pregnant or breastfeeding women
  • People with certain medical conditions (like hyperthyroidism, hypertension, or heart disease) may not be eligible
  • Those with a known allergy to phenol should not undergo this test
  • People taking certain medications (like antihistamines or beta-blockers) may need to stop them before the test
  • The test is not recommended for people with active skin conditions in the test area

What to Expect During the Test

During the clinical trial for this allergen extract, researchers will be looking at several factors:[1]

  • The size of the wheal (raised bump) produced by different concentrations of the allergen extract
  • How this compares to the reaction produced by a standard histamine solution
  • Any side effects or adverse reactions to the test

The test is designed to be as safe and comfortable as possible, but as with any medical procedure, there’s a small risk of side effects. These are usually mild and short-lived, such as itching or redness at the test site.

Aspect Details
Study Drug Phleum Pratense Pollen Extract, Enriched
Purpose Diagnosis of allergy to Phleum pratense and Dactylis glomerata
Primary Objective Determine optimal concentration for skin prick test
Secondary Objective Assess safety and tolerability of allergen extracts
Participant Age Range 18-64 years
Key Inclusion Criteria Positive allergy history, positive skin prick test or specific IgE
Key Exclusion Criteria Recent immunotherapy, unstable clinical conditions, pregnancy
Primary Endpoint Wheal area measurement in skin prick test
Secondary Endpoints Adverse event rate, administration site reactions

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to determine the concentration of Phleum pratense and Dactylis glomerata allergen extracts that causes a skin reaction (wheal) equal in size to that produced by a 10 mg/mL histamine solution during a skin prick test.
  • Who can participate in this clinical trial? Participants must be between 18 and 64 years old, have a history of allergy to Phleum pratense and Dactylis glomerata, show positive skin prick test results or specific IgE antibodies to these allergens, and meet other specific health criteria.
  • What is a skin prick test? A skin prick test is a method used to diagnose allergies. It involves applying a small amount of an allergen extract to the skin and then pricking the skin to allow the substance to enter. If a person is allergic, a small raised bump (wheal) will appear at the test site.
  • Are there any risks associated with participating in this trial? While the trial aims to assess safety, there may be risks such as allergic reactions. People with certain health conditions, pregnancies, or those taking specific medications are excluded to minimize risks. The researchers will monitor participants for any adverse events throughout the study.
  • How will the effectiveness of the allergen extract be measured? The effectiveness will be measured by comparing the size of the wheal (raised bump on the skin) produced by different concentrations of the allergen extract to the wheal produced by a standard histamine solution. The researchers will determine which concentration produces an equivalent reaction.

Ongoing Clinical Trials on Phleum Pratense 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

  • Phleum pratense: Also known as Timothy grass, it is a common cause of grass pollen allergies.
  • Dactylis glomerata: Also known as Orchard grass, another common cause of grass pollen allergies.
  • Allergen extract: A solution containing specific allergens used for diagnosis or treatment of allergies.
  • Wheal: A raised, itchy area on the skin that appears during an allergic reaction or skin prick test.
  • Histamine: A substance released by the body during allergic reactions, used as a positive control in allergy testing.
  • IgE: Immunoglobulin E, an antibody produced by the immune system in response to allergens.
  • Skin prick test: A method of allergy testing where small amounts of allergens are introduced into the skin to observe any reactions.
  • Rhinoconjunctivitis: A condition causing inflammation of the nose and eyes, often due to allergies.
  • Adverse event: Any unfavorable or unintended sign, symptom, or disease that occurs during a clinical trial.

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/