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Study on Stopping Omalizumab in Patients with Well-Controlled Severe Allergic Asthma After 3 Years of Treatment

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What is this trial about?

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

This clinical trial is focused on studying the effects of stopping a medication called omalizumab, which is used to treat a condition known as severe allergic asthma. Severe allergic asthma is a type of asthma that is difficult to control and is triggered by allergies. The medication being studied, omalizumab, is given as an injection and helps to manage asthma symptoms by targeting specific proteins in the body that cause allergic reactions.

The purpose of the study is to see if patients with well-controlled severe allergic asthma can safely stop taking omalizumab after using it for at least three years. Participants in the study will be divided into two groups: one group will continue receiving omalizumab, while the other group will stop the treatment. The study will monitor the number of asthma flare-ups, which are periods when asthma symptoms suddenly get worse, over the course of a year. These flare-ups often require additional medication to manage.

Throughout the study, researchers will also assess changes in asthma control and quality of life, as well as any changes in lung function and the use of other asthma medications. The study aims to determine if stopping omalizumab is as effective as continuing it in maintaining asthma control. Participants will be followed for a total of 12 months to gather this information.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is confirmed for adults over 18 years old with well-controlled severe allergic asthma.

    Participants must have been treated with omalizumab for at least 33 months, prescribed by a pulmonologist.

    Asthma must be well controlled with an ACT score of 18 or higher, with no more than one exacerbation in the previous year.

  2. Step 2

    Randomization

    Participants are randomly assigned to either continue or withdraw from omalizumab treatment.

    The objective is to compare the effects of continuing versus stopping the medication.

  3. Step 3

    Treatment phase

    Participants continuing treatment receive Xolair 75 mg solution for injection, administered subcutaneously.

    The frequency and dosage are determined by the treating pulmonologist based on individual needs.

  4. Step 4

    Monitoring and assessments

    Asthma control is assessed using the Asthma Control Test (ACT) at 6 and 12 months.

    Quality of life and respiratory function are evaluated through questionnaires and FEV1 measurements.

    Changes in medication use, including oral and inhaled steroids, are monitored.

  5. Step 5

    Outcome evaluation

    The primary outcome is the number of asthma exacerbations in the year following randomization.

    Secondary outcomes include changes in asthma control, quality of life, and medication use.

    Emergency room visits and hospitalizations for asthma are recorded.

  6. Step 6

    Study completion

    The study is estimated to end by May 20, 2027.

    Final assessments are conducted to evaluate the long-term effects of omalizumab withdrawal or continuation.

Who can join the trial?

4 criteria

  • Must be an adult over 18 years old.
  • Must have been treated with a medication called Omalizumab, prescribed by a lung specialist, for at least 33 months for **severe allergic asthma**.
  • Asthma must be well controlled with the treatment. This means having an **Asthma Control Test (ACT) score** of 18 or higher. The ACT is a questionnaire that helps measure how well asthma is being managed.
  • Must have had no more than one **exacerbation** in the year before joining the study. An exacerbation is when asthma symptoms get worse and require extra treatment, like taking oral or injectable steroids for at least 2 days, or doubling the usual steroid dose for at least 2 days if the patient depends on steroids.

Who cannot join the trial?

3 criteria

  • Patients who have not been treated with **Omalizumab** for at least 33 months. **Omalizumab** is a medication used to treat severe allergic asthma.
  • Patients who do not have well-controlled severe allergic asthma. This means their asthma symptoms are not being managed effectively.
  • Patients who are part of a vulnerable population. This refers to groups of people who may be at higher risk of harm or exploitation.
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Investigated drugs

Omalizumab is a medication used in this clinical trial to treat severe allergic asthma. It works by targeting and blocking a specific protein in the immune system that can cause asthma symptoms. The trial is investigating the effects of stopping this medication after three years of treatment in patients whose asthma is well controlled, compared to continuing the treatment.

What is already known about the treatment

Omalizumab – This medication is administered via subcutaneous injection and is used primarily for treating severe allergic asthma that is well controlled. It is currently well-established in medical literature and is being studied for its effects when withdrawn after long-term use. Omalizumab works by targeting and inhibiting immunoglobulin E (IgE), a molecule involved in allergic reactions, thereby reducing asthma symptoms. It is classified as a monoclonal antibody and is used to help manage asthma symptoms in patients who do not respond well to standard treatments.

Investigated diseases

Severe Allergic Asthma – Severe allergic asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, triggered by allergens such as pollen, dust mites, or pet dander. Individuals with this condition experience symptoms like wheezing, coughing, shortness of breath, and chest tightness. The severity of symptoms can vary, and they may worsen during exposure to allergens or irritants. Over time, the airways can become more sensitive, leading to frequent asthma attacks or exacerbations. Management often involves avoiding known allergens and using medications to control inflammation and prevent symptoms. Regular monitoring and adjustments in treatment are essential to maintain control over the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513427-17-00Protocol codeAPHP180614Estimated enrolment234 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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