Testing Intralymphatic Allergen Immunotherapy for Teenagers and Adults with Grass Pollen Allergy Causing Hay Fever or Asthma

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What is this study about?

This study is looking at allergic diseases including allergic rhinosinusitis, allergic asthma, and allergy to insect venoms. The main focus is on people who have allergic reactions to grass pollen, which can cause symptoms like a runny or blocked nose, sneezing, and red, itchy, or watery eyes. Some people may also have breathing problems during the grass pollen season. The treatment being tested is called Intralymphatic Allergen Immunotherapy, which involves giving small amounts of allergen extract directly into the lymph nodes. This method is being compared with Sodium chloride solution, which is a salt water mixture.

The purpose of the study is to find out if this type of allergy treatment is effective and safe for teenagers and adults who suffer from moderate to severe allergic reactions to grass pollen. The treatment aims to help reduce allergy symptoms and improve quality of life during the pollen season. The study will measure how well the treatment works by looking at symptom scores, which track how severe the allergy symptoms are, and medication scores, which record how much allergy medicine people need to use. Quality of life questionnaires will also be used to understand how the allergy affects daily activities and well-being.

During the study, participants will receive either the allergen treatment or the salt water solution over a period of several months. The allergen extract used in the treatment contains substances that trigger allergic reactions, and by giving small controlled amounts, the body may learn to tolerate these substances better over time. The study will track symptoms throughout the grass pollen season and measure any changes in how participants feel and function. For those who also have asthma related to grass pollen, additional questionnaires will assess asthma symptoms and control. The entire study will last for about one year, with treatment given over several months and follow-up continuing through the pollen season.

1 Initial assessment and baseline evaluation

Your participation in the study will begin with a baseline assessment. This evaluation will confirm your eligibility based on your grass pollen allergy.

Your allergy will be verified through a skin prick test, which involves placing a small amount of allergen on your skin to check for a reaction. A positive result shows a raised area at least 3 millimeters larger than the control spot.

A blood test will measure your specific IgE antibodies to grass pollen. These are substances in your blood that indicate an allergic response. The minimum level required is 0.5 kU per liter.

You will complete questionnaires to assess your current symptoms and quality of life. These include the Rhino-conjunctivitis Quality of Life Questionnaire, which evaluates how your nose and eye symptoms affect your daily activities.

If you have asthma, you will also complete the Asthma Quality of Life Questionnaire and the Asthma Control Test to assess how well your asthma is managed.

2 Treatment phase with intralymphatic immunotherapy

You will receive intralymphatic allergen immunotherapy, abbreviated as ILIT. This treatment involves injecting allergen extract directly into a lymph node rather than under the skin as in traditional allergy shots.

The treatment uses commercial allergen extracts specifically prepared for grass pollen allergy.

Some participants will receive the active allergen extract, while others will receive sodium chloride solution (9 milligrams per 1000 milliliters), which is a salt water solution used as a comparison treatment.

The injections will be administered via the intralymphatic route, meaning the substance will be injected directly into your lymph nodes. Lymph nodes are small organs that are part of your immune system.

The specific number of injections, exact dosage, and intervals between treatments will be determined according to the study protocol.

3 Symptom and medication tracking during pollen season

Throughout the grass pollen season, you will record your symptoms daily using a symptom score system. This involves rating six symptoms on a scale from 0 to 3, where 0 means no symptoms and 3 means severe symptoms.

The nasal symptoms you will track are: runny nose, blocked nose, and sneezing.

The eye symptoms you will track are: red eyes, itchy eyes, and watery eyes.

Your total symptom score can range from 0 to 18 points.

You will also keep a detailed record of all medications you use for your allergy symptoms. This includes counting the exact number of antihistamine tablets you take, the number of nasal corticosteroid puffs you use, and any eye drops you apply.

This information will be recorded as your medication score.

4 Quality of life assessments

At designated time points during the study, you will complete the Rhino-conjunctivitis Quality of Life Questionnaire. This questionnaire evaluates how your nose and eye allergy symptoms impact various aspects of your life.

If you have asthma related to grass pollen, you will also complete two additional questionnaires.

The Asthma Quality of Life Questionnaire assesses how your asthma affects your daily activities and overall well-being.

The Asthma Control Test measures how well your asthma symptoms are controlled over time.

5 Safety monitoring

Throughout the study, your safety will be monitored continuously. Any side effects or adverse reactions you experience will be documented.

You should report any unusual symptoms or reactions following the injections or at any point during your participation.

This monitoring is essential to evaluate the safety profile of the intralymphatic allergen immunotherapy approach.

6 Final evaluation

At the conclusion of the study, a final assessment will be conducted to evaluate the overall effectiveness of the treatment.

This will include a review of your symptom scores, medication usage, and quality of life questionnaire responses collected throughout the study period.

The data will help determine whether intralymphatic allergen immunotherapy is effective in reducing allergy symptoms and improving quality of life for individuals with grass pollen allergy.

Who Can Join the Study?

You must be 18 years old or older
You must have moderate to severe allergic rhino-conjunctivitis, which means allergies affecting your nose and eyes that cause significant symptoms
Your allergy must be caused by grass pollen
You must have a positive skin prick test, which is a test where small amounts of allergens are placed on your skin to see if you react. The reaction bump must be at least 3 millimeters larger than the control spot
You must have specific IgE antibodies in your blood to grass pollen. IgE antibodies are proteins your immune system makes when you have an allergy. The level must be at least 0.5 kU/l, which is a measurement unit for these antibodies
You may have mild to moderate seasonal asthma caused by grass pollen, but this is not required. Seasonal asthma means breathing difficulties that occur during certain times of the year when grass pollen is present

Who Cannot Join the Study?

The study does not list specific exclusion criteria, which means the research team will determine during screening if you are suitable to participate based on your individual health situation and medical history.
You should discuss with the study doctor if you have any serious health conditions, as these may affect your ability to participate safely.
If you are taking certain medications or have undergone specific treatments, the study doctor will need to review these to determine if they might interfere with the study.
Women who are pregnant (expecting a baby) or breastfeeding (nursing a baby) may not be able to participate, as this is common in clinical trials to protect the mother and baby.
If you have severe asthma (a breathing condition where airways become narrow and swollen) that is not well controlled, you may not be eligible to participate.
People with serious heart, liver, kidney, or immune system diseases may not be able to join the study for safety reasons.
If you have previously had a severe allergic reaction (a serious response by your body’s defense system) to immunotherapy (treatment that helps your immune system fight allergies), you may be excluded.
Active autoimmune diseases (conditions where your body’s defense system attacks itself) or cancer may prevent you from participating.
The study doctor will provide you with a complete list of reasons why you might not be able to participate during your screening visit.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Uansslqoau Oh Fmejru	Foggia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.10.2025

Trial locations

Grass pollen allergen extract is a substance made from grass pollen that is used to help your body become less sensitive to grass pollen over time. In this study, the allergen extract will be injected into your lymph nodes, which are small organs that are part of your immune system. This treatment method is called intralymphatic allergen immunotherapy. The goal is to reduce allergic symptoms like sneezing, runny nose, itchy eyes, and breathing problems that occur when you are exposed to grass pollen.

Investigated diseases:

Conjunctivitis allergic

Allergic Rhinosinusitis – Allergic rhinosinusitis is a condition where the nasal passages and sinuses become inflamed due to an allergic reaction to airborne substances such as pollen, dust mites, or animal dander. When a person with this condition breathes in an allergen, their immune system overreacts and releases chemicals that cause inflammation. Common symptoms include a runny or blocked nose, sneezing, facial pressure, and reduced sense of smell. The condition can occur seasonally, such as during pollen seasons, or year-round depending on the allergen. Symptoms may range from mild to severe and can significantly affect daily activities and sleep quality. The inflammation can affect both the nasal passages and the connected sinus cavities, leading to discomfort in the face and around the eyes.

Allergic Asthma – Allergic asthma is a type of asthma triggered by breathing in allergens such as pollen, mold spores, pet dander, or dust mites. When an allergic person inhales these substances, their airways become inflamed, swollen, and produce extra mucus. This leads to narrowing of the airways, making it difficult to breathe. Common symptoms include wheezing, coughing, shortness of breath, and chest tightness. The symptoms can vary in intensity and may worsen during certain seasons or after exposure to specific allergens. Episodes of breathing difficulty can occur suddenly and may be accompanied by other allergic symptoms such as sneezing or itchy eyes.

Hymenoptera Venom Allergy – Hymenoptera venom allergy is an allergic reaction to stings from insects belonging to the Hymenoptera order, which includes bees, wasps, hornets, and fire ants. When a person with this allergy is stung, their immune system overreacts to proteins in the insect venom. Reactions can range from large local swelling at the sting site to more widespread symptoms affecting the whole body. Symptoms may include hives, itching, swelling of the face or throat, difficulty breathing, rapid heartbeat, dizziness, and digestive problems. The severity of reactions can vary from person to person and may change over time. Some individuals may experience increasingly severe reactions with subsequent stings.

Trial ID:

2025-522376-82-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Testing Intralymphatic Allergen Immunotherapy for Teenagers and Adults with Grass Pollen Allergy Causing Hay Fever or Asthma

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