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Phleum Pratense (225)

This article discusses recent clinical trials investigating the use of Phleum Pratense (225), commonly known as Timothy grass pollen extract, in treating moderate to severe allergic rhinitis and rhinoconjunctivitis. These studies aim to evaluate the efficacy and safety of different immunotherapy approaches using this allergen extract to improve symptoms and quality of life for grass pollen allergy sufferers.

Table of Contents

What is Phleum Pratense (225)?

Phleum pratense (225), also known as Timothy Grass, is a type of grass pollen that is commonly used in allergy treatments[1]. It is an allergen extract derived from timothy grass, which is a common cause of hay fever and other allergic reactions in many people. This substance is used in various forms of immunotherapy to help reduce allergic reactions to grass pollen.

Medical Conditions Treated

Phleum pratense (225) is primarily used to treat moderate-to-severe allergic rhinitis and rhinoconjunctivitis caused by grass pollen allergy[2]. These conditions involve symptoms such as:

  • Sneezing
  • Runny or stuffy nose
  • Itchy or watery eyes
  • Itchy throat or ears

The treatment is typically recommended for patients who have experienced these symptoms for at least two years and whose symptoms are not adequately controlled by conventional allergy medications.

Forms of Treatment

Phleum pratense (225) is administered in several forms of immunotherapy:

  1. Sublingual Immunotherapy (SLIT): This involves taking a tablet or drops containing the allergen extract under the tongue daily[3]. An example of this is GRAZAX, a sublingual tablet containing 75,000 SQ-T units of Phleum pratense extract.
  2. Subcutaneous Immunotherapy (SCIT): This involves receiving injections of the allergen extract under the skin, typically administered by a healthcare professional[3]. Alutard SQ Timotej is an example of a product used for SCIT, containing 10,000 SQ-E/ml of Phleum pratense extract.
  3. Intralymphatic Immunotherapy (ILIT): This is a newer form of treatment being studied, where the allergen extract is injected directly into lymph nodes[3].

Effectiveness

Clinical trials have shown that immunotherapy with Phleum pratense (225) can be effective in reducing allergy symptoms and the need for medication during grass pollen season. The effectiveness is typically measured using the Combined Symptom and Medication Score (CSMS), which takes into account both the severity of allergy symptoms and the amount of rescue medication needed[2][3].

Patients often experience improvement in their quality of life, as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)[3]. The treatment can also increase the number of “well days” during pollen season, defined as days with minimal symptoms and no need for rescue medication.

Side Effects and Safety

While immunotherapy with Phleum pratense (225) is generally considered safe, it can cause side effects. Common side effects may include:

  • Itching or swelling in the mouth (for sublingual therapy)
  • Local reactions at the injection site (for subcutaneous therapy)
  • Mild allergic reactions

In rare cases, more severe allergic reactions can occur. Therefore, the treatment is typically started under medical supervision, and patients are monitored for adverse reactions[2].

Ongoing Research

Current research is exploring new ways to improve the effectiveness and safety of immunotherapy with Phleum pratense (225). Some areas of ongoing study include:

  • Combining immunotherapy with vitamin D supplementation to potentially enhance its effects[3]
  • Comparing the effectiveness of different routes of administration (sublingual vs. subcutaneous vs. intralymphatic)[3]
  • Investigating optimal dosing regimens to maximize effectiveness while minimizing side effects[2]

These studies aim to provide more personalized and effective treatment options for patients with grass pollen allergies in the future.

Aspect Details
Study Types Phase II-III clinical trials
Main Objective To assess efficacy and safety of Phleum Pratense (225) immunotherapy for grass pollen allergy
Treatment Methods Sublingual immunotherapy (SLIT), Intralymphatic immunotherapy (ILIT)
Target Population Adults 18-65 with moderate to severe grass pollen allergic rhinitis/rhinoconjunctivitis
Primary Outcome Combined Symptom and Medication Score (CSMS) during peak pollen season
Secondary Outcomes Quality of life, individual symptom scores, immunological markers
Innovative Approaches Combination of ILIT with vitamin D supplementation
Safety Assessments Monitoring of adverse events, lung function tests (for asthmatic patients)

FAQ

  • What is Phleum Pratense (225) and how is it used in allergy treatment? Phleum Pratense (225) is an allergen extract from Timothy grass pollen. It's used in immunotherapy treatments for grass pollen allergies, aiming to reduce allergy symptoms by gradually exposing patients to small amounts of the allergen.
  • What types of immunotherapy are being studied with Phleum Pratense (225)? The clinical trials are exploring different immunotherapy approaches, including sublingual immunotherapy (SLIT), where the extract is placed under the tongue, and intralymphatic immunotherapy (ILIT), where it's injected directly into lymph nodes.
  • Who are the target patients for these clinical trials? The trials are focusing on adults aged 18-65 with moderate to severe allergic rhinitis or rhinoconjunctivitis due to grass pollen, who have had symptoms for at least two years and meet specific criteria for grass pollen sensitization.
  • What are the main outcomes being measured in these trials? The primary outcome in most trials is the Combined Symptom and Medication Score (CSMS) during peak pollen season. Secondary outcomes include quality of life measures, individual symptom scores, and various immunological markers.
  • Are there any innovative approaches being tested alongside Phleum Pratense (225)? Yes, one trial is investigating the combination of intralymphatic immunotherapy with vitamin D supplementation to potentially enhance the treatment's effectiveness for grass pollen allergies.

Ongoing Clinical Trials on Phleum Pratense (225)

  • Study on the Effectiveness of Intralyphatic Immunotherapy with Vitamin D for Patients with Allergic Rhinitis Using Phleum Pratense and Colecalciferol

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on the Effectiveness and Safety of Phleum Pratense Pollen Extract for Patients with Moderate-to-Severe Grass Pollen Allergy

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effectiveness and Safety of Sublingual Immunotherapy with Betula Pendula Pollen Extract for Patients with Birch Pollen Allergy

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Allergic rhinitis: An allergic reaction affecting the nasal passages, causing symptoms like sneezing, runny nose, and nasal congestion in response to allergens such as pollen.
  • Rhinoconjunctivitis: A combination of allergic symptoms affecting both the nasal passages (rhinitis) and the eyes (conjunctivitis), commonly occurring in response to airborne allergens like pollen.
  • Sublingual immunotherapy (SLIT): A form of allergy treatment where an allergen extract is placed under the tongue to help the body build tolerance to the allergen over time.
  • Intralymphatic immunotherapy (ILIT): An allergy treatment method where allergen extracts are injected directly into lymph nodes to stimulate the immune system and build tolerance.
  • Combined Symptom and Medication Score (CSMS): A standardized measure used in allergy research to assess the severity of allergy symptoms and the amount of medication needed to control them.
  • Peak Pollen Period (PPP): The time during allergy season when pollen counts are at their highest, typically causing the most severe allergy symptoms.
  • Sensitization: The process by which the immune system becomes reactive to a specific allergen, leading to allergy symptoms upon subsequent exposures.
  • Skin Prick Test (SPT): A diagnostic test used to identify specific allergies by observing skin reactions to small amounts of potential allergens.
  • Forced Expiratory Volume (FEV1): A measure of lung function that represents the amount of air a person can forcefully exhale in one second.
  • Quality of Life Questionnaire (RQLQ): A standardized survey used to assess how allergic rhinitis impacts a patient's daily life and overall well-being.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-sublingual-immunotherapy-with-betula-pendula-pollen-extract-for-patients-with-birch-pollen-allergy/
  2. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-sublingual-immunotherapy-with-vitamin-d-for-patients-with-moderate-to-severe-grass-pollen-allergy/
  3. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-intralyphatic-immunotherapy-with-vitamin-d-for-patients-with-allergic-rhinitis-using-phleum-pratense-and-colecalciferol/