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

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people who have been suffering from moderate-to-severe allergic rhinitis or rhinoconjunctivitis due to olive pollen for at least two years. The treatment being tested is called CLU-RX-OLE, which is a type of immunotherapy given through injections. The study aims to find the most effective and well-tolerated dose of this treatment. Participants in the study will receive either the CLU-RX-OLE treatment or a placebo, which looks like the treatment but does not contain the active ingredient.

During the study, participants will be monitored to see how their symptoms change over time. The study will compare the symptoms and medication use of those receiving the active treatment with those receiving the placebo. This will help determine the treatment’s effectiveness in reducing symptoms and improving the quality of life for those with olive pollen allergies. The study will also assess the safety and any side effects of the treatment.

The trial will take place over a period of time, with participants being asked to keep track of their symptoms and any medications they use. This information will be used to evaluate the treatment’s impact on their condition. The goal is to find a balance between the benefits and any potential risks of the treatment, ensuring it is both effective and safe for patients with olive pollen allergies.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a history of moderate-to-severe allergic rhinitis or rhinoconjunctivitis due to olive pollen for at least two years.

A skin prick test is performed to confirm sensitization to Olea europaea pollen. A positive result is indicated by a wheal diameter of at least 3 mm.

2 baseline evaluation

A baseline evaluation is conducted to establish initial health parameters. This includes completing an electronic diary for self-evaluation of symptoms and rescue medication use.

Safety laboratory tests are performed to ensure results are within normal ranges or not clinically significant.

3 treatment phase

The treatment phase involves subcutaneous cluster-immunotherapy with CLU-RX-OLE, which is an allergenic extract of Olea europaea pollen.

The treatment is administered through injections, with doses adjusted to determine the most effective and best-tolerated dose.

4 medication administration

During the trial, medications such as mometasone furoate nasal spray and loratadine tablets may be used to manage symptoms.

Mometasone furoate is administered as a nasal spray, while loratadine is taken orally in tablet form.

5 monitoring and evaluation

Throughout the trial, symptoms and medication use are monitored using the electronic diary.

Regular assessments are conducted to evaluate the efficacy and safety of the treatment, including the Combined Symptom and Medication Score (CSMS) during the peak olive pollen period.

6 final assessment

At the end of the trial, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

The results are compared to the baseline evaluation to determine any improvements in symptoms and quality of life.

Who Can Join the Study?

Patients must have signed and dated the informed consent form before any study-specific examination.
Participants can be female or male and must be between 18 and 65 years old at the time of signing the informed consent form.
Patients should have had moderate-to-severe allergic rhinitis (a condition causing sneezing, stuffy or runny nose) or rhinoconjunctivitis (similar symptoms affecting the eyes) due to olive pollen for at least two years. This should be according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline. They can have mild-to-moderate asthma that is well-controlled or no asthma at all.
For patients with asthma, their forced expiratory volume (FEV1) in one second should be more than 80% of the predicted normal value. FEV1 is a measure of how much air a person can forcefully exhale in one second.
Patients must be sensitized to Olea europaea pollen, which means they have an allergic reaction to it. This is verified by a positive skin prick test and a specific blood test showing a certain level of allergy antibodies (IgE) to Olea europaea. They should also have a certain score on a symptom scale based on their worst days in the past and a positive response to a nasal test with olive pollen or a similar allergen.
Patients must be able to understand and use an electronic diary to record their symptoms and any medication they take. They should be able to follow the instructions given by the study staff.
Laboratory test results should be within the normal range or not considered to be of clinical concern.

Who Cannot Join the Study?

Patients who have not experienced moderate-to-severe allergic reactions to olive pollen for at least two years.
Patients who do not meet the guidelines for allergic rhinitis or rhinoconjunctivitis, which are conditions involving inflammation of the nose and eyes due to allergies.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they may need special protection or care.

Where you can join this trial?

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Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	02.09.2024

Trial locations

Investigated drugs:

CLUSTOID®/CLUXIN® Olea europaea is a type of immunotherapy used in this clinical trial. It is designed to help patients who are allergic to Olea europaea pollen, commonly known as olive tree pollen. The therapy involves administering the treatment under the skin in a series of doses. The goal is to gradually increase the patient’s tolerance to the pollen, reducing allergic symptoms and the need for other allergy medications. This study aims to find the most effective and well-tolerated dose for patients, balancing the benefits and any potential risks.

Allergic Rhinitis – Allergic rhinitis is a condition characterized by inflammation of the nasal passages due to an allergic reaction. It is often triggered by allergens such as pollen, dust, or pet dander. Symptoms include sneezing, runny or stuffy nose, itchy eyes, and throat. The condition can be seasonal, as in hay fever, or perennial, occurring year-round. Over time, exposure to allergens can lead to persistent symptoms and discomfort. The severity of symptoms can vary, with some individuals experiencing mild irritation and others facing more significant disruption to daily activities.

Trial ID:

2024-511383-88-00

Protocol code:

SC-3C2A

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?