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Olea Europaea Pollen Extract

Recent clinical trials are investigating the use of Olea Europaea Pollen Extract as a potential treatment for individuals suffering from moderate to severe allergic reactions to olive pollen. This article delves into the ongoing research, focusing on a Phase II-III study that aims to assess the efficacy and safety of subcutaneous cluster-immunotherapy using this extract. The study targets patients with allergic rhinitis or rhinoconjunctivitis caused by olive pollen, exploring various dosages to determine the most effective and well-tolerated treatment option.

Table of Contents

What is Olea Europaea Pollen Extract?

Olea Europaea Pollen Extract, also known as olive pollen extract, is a substance derived from olive tree pollen. It is being studied as a potential treatment for people who suffer from allergies to olive pollen[1]. This extract is used in a form of treatment called subcutaneous immunotherapy, which involves injecting small amounts of the allergen under the skin to help the body build tolerance over time.

Medical Condition Treated

The primary medical condition targeted by this treatment is moderate-to-severe allergic rhinitis or rhinoconjunctivitis caused by olive pollen[1]. These conditions involve inflammation of the nasal passages (rhinitis) and eyes (conjunctivitis) due to an allergic reaction to olive pollen. Symptoms may include:

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

The condition must have been present for at least two years, as defined by the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline[1].

How It Works

Olea Europaea Pollen Extract is used in a treatment called subcutaneous cluster-immunotherapy. This therapy works by exposing the immune system to small, controlled amounts of the allergen (in this case, olive pollen). Over time, this exposure can help the body build tolerance to the allergen, reducing allergic reactions when naturally exposed to olive pollen[1].

Clinical Trial Details

A Phase II-III clinical trial is being conducted to assess the efficacy and safety of this treatment[1]. The main objective of the trial is to determine the most effective and best-tolerated dose of the extract. The study will measure the Combined Symptom and Medication Score (CSMS), which takes into account both the severity of allergy symptoms and the amount of medication needed to control them[1].

Eligibility Criteria

To participate in the clinical trial, patients must meet specific criteria, including:

  • Age between 18 and 65 years
  • Diagnosed with moderate-to-severe allergic rhinitis or rhinoconjunctivitis due to olive pollen for at least two years
  • Positive skin prick test and blood test for olive pollen allergy
  • No previous immunotherapy with olive pollen or related allergens in the past 5 years

There are also several exclusion criteria, such as severe asthma, certain immune system disorders, and pregnancy[1].

Potential Benefits

If successful, this treatment could provide several benefits for patients with olive pollen allergies:

  • Reduced allergy symptoms during olive pollen season
  • Decreased need for allergy medications
  • Improved quality of life during pollen season
  • Potential long-term reduction in allergy severity

The clinical trial will measure these outcomes using various methods, including symptom scores, medication use, and quality of life questionnaires[1].

Safety and Side Effects

As with any medical treatment, there are potential risks and side effects. The clinical trial will closely monitor participants for any adverse reactions. Common side effects of immunotherapy can include:

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

The study will analyze the safety and tolerability of each dose compared to a placebo, tracking any Treatment-Emergent Adverse Drug Reactions (TEADRs)[1].

Aspect Details
Study Type Phase II-III clinical trial
Treatment Subcutaneous cluster-immunotherapy with Olea Europaea Pollen Extract
Target Condition Moderate to severe allergic rhinitis/rhinoconjunctivitis due to olive pollen
Primary Endpoint Difference in Combined Symptom and Medication Score (CSMS) during Peak Olive Pollen Period
Key Eligibility Criteria Adults 18-65, positive skin prick test and specific IgE to Olea europaea
Safety Assessment Analysis of Treatment-Emergent Adverse Drug Reactions (TEADR)
Secondary Endpoints Quality of life, symptom-free days, nasal provocation test results

FAQ

  • What is the main purpose of the clinical trial using Olea Europaea Pollen Extract? The main purpose of the trial is to determine the most effective and best-tolerated dose of CLUSTOID®/CLUXIN® Olea europaea in terms of benefit-risk balance and Combined Symptom and Medication Score (CSMS) for patients with moderate to severe olive pollen allergy.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults aged 18-65 with moderate to severe allergic rhinitis or rhinoconjunctivitis due to olive pollen for at least two years. They must have a positive skin prick test and specific IgE to Olea europaea, among other criteria. Patients with well-controlled mild to moderate asthma may also be included.
  • What is the primary endpoint of the study? The primary endpoint is the absolute difference in mean Combined Symptom and Medication Score (CSMS) during the Peak Olive Pollen Period (POPP) between each active treatment group and the placebo treatment group.
  • How is the safety of the treatment being evaluated? The safety and tolerability of each dose of CLU-RX-OLE compared to placebo are being analyzed through Treatment-Emergent Adverse Drug Reactions (TEADR) and the number of patients affected with TEADRs in each group.
  • What are some of the exclusion criteria for this trial? Some exclusion criteria include previous immunotherapy with Olea europaea or related pollen allergens within the last 5 years, serious systemic reactions to allergen-specific immunotherapy in the past, severe or unstable lung diseases, and certain immune system disorders. Pregnant or lactating women are also excluded.

Ongoing Clinical Trials on Olea Europaea Pollen Extract

  • Study of Grass Pollen Extract and Olive Pollen Extract for Patients with Hay Fever and Asthma caused by Grass and Olive Pollen Allergies

    Not yet recruiting

    3 1
    Investigated drugs:
    Portugal Spain

  • Standardization of Olea europaea pollen extract for patients with olive pollen allergies

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of Allergenic Extract of Olea Europaea Pollen for Patients with Moderate-to-Severe Olive Pollen Allergy

    Not recruiting

    4 1 1
    Investigated drugs:
    Spain

Glossary

  • Allergic rhinitis: An allergic reaction affecting the nose, causing symptoms such as sneezing, runny nose, and nasal congestion in response to allergens like pollen.
  • Rhinoconjunctivitis: A condition where both the nose and eyes are affected by an allergic reaction, causing symptoms in both areas.
  • Subcutaneous cluster-immunotherapy: A type of allergy treatment where allergen extracts are injected under the skin in a series of increasing doses, administered in clusters to build tolerance more quickly.
  • Combined Symptom and Medication Score (CSMS): A measure used to assess the severity of allergy symptoms and the amount of medication needed to control them.
  • Peak Olive Pollen Period (POPP): The time of year when olive pollen concentrations in the air are at their highest levels.
  • Skin prick test: A diagnostic test where small amounts of allergens are pricked into the skin to check for allergic reactions.
  • Specific IgE: Antibodies produced by the immune system in response to specific allergens, measured to diagnose allergies.
  • Forced expiratory volume (FEV1): A measure of lung function, specifically how much air a person can exhale in one second.
  • Treatment-Emergent Adverse Drug Reactions (TEADR): Side effects or unwanted reactions that occur during or after treatment with a medication.
  • Titrated Nasal Provocation Test (tNPT): A test where increasing doses of an allergen are applied to the nose to determine the threshold at which symptoms occur.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-allergenic-extract-of-olea-europaea-pollen-for-patients-with-moderate-to-severe-olive-pollen-allergy/