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Study of bilastine for effectiveness, safety and quality of life in children aged 6 to 12 years with allergic rhinoconjunctivitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at allergic rhinoconjunctivitis, which is a condition that causes symptoms like sneezing, runny nose, itching in the nose, watery eyes, and itching in the eyes when a person is exposed to things they are allergic to, such as pollen or dust. The treatment being tested is bilastine, which is an allergy medicine that helps reduce these symptoms. The medicine comes in a form that dissolves in the mouth and is taken once daily.

The purpose of this study is to see how well bilastine works in children between 6 and 11 years old who have allergic rhinoconjunctivitis, and to check if it is safe and if it improves their quality of life. Children in the study will take 10 milligrams of bilastine every day for 14 days. During the study, the children or their parents will record allergy symptoms each day using an electronic diary, noting how severe the symptoms like sneezing, runny nose, itching, and watery eyes have been over the previous day.

The study will measure changes in these five main symptoms from the beginning of the treatment to the end of the 14-day period to determine if the medicine is effective. Children participating in the study must have had allergic rhinoconjunctivitis for at least one year and must have allergy symptoms at the time they join the study. They also need to have had a positive allergy test in the past year and must have responded well to allergy medicines before. The study will also include some basic health checks like blood tests and heart rhythm tests to make sure the children are healthy enough to participate.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and enrollment

    At the screening visit, your current allergy symptoms will be assessed. Your symptoms must include at least a moderate level of sneezing, runny nose, nasal itching, tearing, and eye itching, with a combined score of at least 8 points out of 15.

    A 12-lead electrocardiogram (a test that records the electrical activity of your heart) will be performed to ensure there are no significant abnormalities.

    Your previous laboratory test results (blood count and biochemistry) will be reviewed to confirm that all values are within the normal range.

    Your medical history will be verified to confirm that you have had allergic rhinoconjunctivitis (an allergic condition affecting the nose and eyes) for at least one year and that you have previously responded well to allergy medications taken by mouth.

    Documentation of a positive skin prick test (a test where small amounts of allergens are placed on the skin) or a positive specific IgE blood test (a blood test that measures allergic antibodies) performed within the past year will be confirmed.

  2. Step 2

    Baseline visit and treatment start

    This visit marks the beginning of the treatment period and is referred to as Visit 1 or baseline.

    Your allergy symptoms will be recorded at this visit to establish a starting point for comparison.

    You will receive Bilaxten Flas 10 mg orodispersible tablets (tablets that dissolve in the mouth without water). The active ingredient in this medication is bilastine, which is an antihistamine used to treat allergy symptoms.

    You will be instructed to take one tablet daily by mouth.

    You will be provided with an electronic diary (e-diary) to record your symptoms each day. Each day, you will rate five specific symptoms: sneezing, runny nose, nasal itching, tearing, and eye itching. These ratings should reflect how you felt during the previous 12 to 24 hours.

  3. Step 3

    Daily treatment period

    You will take one 10 mg bilastine orodispersible tablet daily for a total of 14 days.

    Each day during this period, you will complete entries in your electronic diary, recording your allergy symptoms from the previous 12 to 24 hours.

    The symptoms to be recorded daily include: sneezing, runny nose, nasal itching, tearing, and eye itching.

  4. Step 4

    Final assessment visit

    After completing 14 days of daily treatment, you will attend a final assessment visit, referred to as Visit 3.

    At this visit, your allergy symptoms will be evaluated again using the same five-symptom scoring system used at the baseline visit.

    The change in your symptom scores from the beginning of the study to this final visit will be calculated to determine the effectiveness of the medication.

    Your overall safety and any changes in your quality of life during the treatment period will also be assessed.

Who can join the trial?

10 criteria

  • The child must be 6 years old or older but younger than 12 years old and weigh at least 15 kilograms at the time of joining the study
  • The child can be male or female
  • The child must have a documented medical history of allergic rhinoconjunctivitis, which is an allergic condition that causes sneezing, runny nose, itchy nose, watery eyes, and itchy eyes, for at least 1 year
  • The child must have mild to moderate symptoms of allergic rhinoconjunctivitis at the time of joining the study
  • The child must have had a positive allergy test within the past year, either a skin prick test showing a bump of at least 3 millimeters or a blood test showing specific allergy antibodies greater than 0.70 for at least one substance that causes allergies
  • The child must have a medical history showing that they responded well to oral antihistamine treatment, which are medicines taken by mouth that help reduce allergic symptoms
  • The child must have a symptom score of at least 8 points out of 15 for five specific symptoms at the first visit, including sneezing, runny nose, itchy nose, watery eyes, and itchy eyes
  • The child must have had at least one blood test before joining the study that shows no significant health problems, or if there were any abnormal results in the past, a new test must show that values have returned to normal
  • The child must have had a heart tracing test called an ECG with 12 leads that shows no significant heart problems
  • The parents or legal guardian must provide written permission for the child to participate in the study, and the child may also need to sign an agreement form if required

Who cannot join the trial?

4 criteria

  • The study does not list specific exclusion criteria in the provided information, meaning the detailed reasons why a patient cannot participate are not available in this data
  • Generally, clinical trials have standard exclusion criteria that may include having other serious health conditions, taking certain medications that could interfere with the study drug, or having allergies to the study medication
  • Children outside the age range of 6 to less than 12 years old cannot participate in this study
  • Patients who do not have allergic rhinoconjunctivitis, which is an allergic condition causing symptoms like sneezing, runny nose, itchy nose, watery eyes, and itchy eyes, cannot participate
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Investigated drugs

Bilastine is an antihistamine medication used to treat symptoms of allergic rhinoconjunctivitis, which is an allergic condition that affects both the nose and eyes. This medicine helps relieve common allergy symptoms such as sneezing, runny nose, itchy nose, watery eyes, and itchy eyes. In this study, bilastine is given as an orally disintegrating tablet (ODT), which is a type of tablet that dissolves quickly in the mouth without needing water.

What is already known about the treatment

Bilastine – Bilastine is an antihistamine medication available in an orally disintegrating tablet (ODT) form that dissolves quickly in the mouth without water, making it easy for children to take. It is currently approved and used in medical practice to treat allergic rhinoconjunctivitis, a condition that causes symptoms like sneezing, runny nose, itchy nose, watery eyes, and itchy eyes due to allergies. The medication works by blocking histamine, a natural substance in the body that causes allergic symptoms, specifically by preventing histamine from attaching to its receptors on cells, which helps reduce inflammation and allergic reactions. Bilastine belongs to the class of second-generation antihistamines, which are preferred because they effectively control allergy symptoms while causing less drowsiness compared to older antihistamine medications.

Investigated diseases

Allergic Rhinoconjunctivitis – Allergic rhinoconjunctivitis is a condition where the body's immune system overreacts to substances in the air, such as pollen, dust mites, or pet dander. When these substances come into contact with the nose and eyes, they trigger an allergic response. The condition affects both the nasal passages and the eyes at the same time. Common symptoms include sneezing, a runny nose, itching in the nose, watery eyes, and itching in the eyes. These symptoms occur because the body releases chemicals like histamine when exposed to allergens. The condition can be seasonal, occurring during specific times of the year, or it can happen year-round depending on what triggers the allergic reaction.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-519550-36-00Protocol codeBILA-4124/PEDEstimated enrolment70 patientsSponsorA. Menarini Industrie Farmaceutiche Riunite S.r.l.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).