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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Victor Dupouy Argenteuil France
Hospital Foch Suresnes France
Les Hopitaux De Chartres Le Coudray France
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Centre Hospitalier De Roubaix Roubaix France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopitaux Prives De Metz Vantoux France
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Direction Centrale Du Service De Sante Des Armees Toulon France
Les Hopitaux Nord-Ouest Villefranche sur Saône France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Centre Hospitalier Tarbes-Lourdes Tarbes France
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Gshkoa Hhgcrmasibb Ueextgibftgar Pauri Peaopzkseav Eu Nrmeofnphngr Paris France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
20.05.2021

Trial locations

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.

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 ID:
2024-513427-17-00
Protocol code:
APHP180614
NCT ID:
NCT04763447
Trial Phase:
Therapeutic confirmatory (Phase III)

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