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Study on Adjusting Omalizumab Dosage for Patients with Severe Allergic Asthma

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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 a medication called omalizumab on patients with allergic severe asthma. Omalizumab is a solution for injection that is used to help manage asthma symptoms. The study will explore whether reducing the dose of omalizumab by 50% can maintain the same level of asthma control in patients. This control is measured by the absence of asthma attacks, the quality of life, and lung function.

Participants in the study will receive either a reduced dose of omalizumab or a placebo. The study aims to determine if the reduced dose is as effective as the current standard dose in keeping asthma symptoms stable. The trial will involve regular check-ups to monitor the participants' health and response to the treatment.

The study will last for a period of time during which participants will be closely observed to ensure their safety and to gather data on the effectiveness of the dose adjustment. The goal is to find an optimal dosing strategy that could potentially improve treatment outcomes for people with allergic severe asthma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 18 and 80 years, ensuring adherence to omalizumab treatment, and confirming stable lung function.
The assessment also checks for the absence of emergency visits or hospital admissions related to asthma in the past six months.
Step 2
Informed consent
Participants must understand and sign an informed consent form. This document explains the study's purpose, procedures, and potential risks and benefits.
Step 3
Omalizumab administration
Participants receive omalizumab, a medication used to treat severe allergic asthma. It is administered as a subcutaneous injection.
The study involves adjusting the dose and frequency of omalizumab. The aim is to evaluate if a 50% dose reduction maintains clinical stability, assessed by the absence of asthma crises, quality of life, and lung function.
Step 4
Regular follow-up visits
Participants attend regular follow-up visits, either in-person or via telephone, to monitor their condition and adjust treatment as necessary.
These visits assess the participant's asthma control, quality of life, and lung function.
Step 5
End of study evaluation
At the end of the study, a final evaluation is conducted to assess the overall effectiveness of the dose adjustment strategy.
The study is expected to conclude by March 24, 2026.

Who can join the trial?

8 criteria

Patients must be between 18 and 80 years old.
Patients must have taken their medication, called omalizumab, exactly as prescribed for the past 6 months.
Patients must have an ACT score of 19 or higher. The ACT score is a way to measure how well asthma is being controlled.
Patients must have stable lung function, with a FEV1 of more than 80%. FEV1 is a test that measures how much air you can blow out of your lungs in one second.
Patients must not have used oral corticosteroids in the past 6 months. Oral corticosteroids are a type of medication used to reduce inflammation.
Patients must not have visited the emergency room or been admitted to the hospital in the past 6 months.
Patients must be willing to attend in-person or phone visits as part of the study.
Patients must understand, agree to, and sign a document called an informed consent. This document explains the study and confirms the patient's willingness to participate. A legal guardian can also provide permission if needed.

Who cannot join the trial?

3 criteria

Patients who do not have allergic asthma cannot participate. Allergic asthma is a type of asthma triggered by allergens like pollen, dust, or pet dander.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain
Verified
Hospital Vall d’Hebron
Barcelona, Spain

Trial locations

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Investigated drugs

Omalizumab is a medication used in this clinical trial to help manage severe allergic asthma. It works by targeting and blocking a specific protein in the immune system that can cause asthma symptoms. The trial aims to see if reducing the dose of omalizumab by 50% can still maintain the same level of asthma control, as measured by the absence of asthma attacks, quality of life, and lung function.

Omalizumab

What is already known about the treatment

Omalizumab – Omalizumab is administered via subcutaneous injection, typically under the skin. It is currently well-established in medical literature as a treatment for severe allergic asthma. The main therapeutic indication for omalizumab is to help control symptoms in patients with severe asthma that is not adequately managed with standard treatments. At the molecular level, omalizumab works by binding to immunoglobulin E (IgE), a type of antibody involved in allergic reactions, thereby preventing it from attaching to receptors on immune cells and reducing allergic inflammation. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Asthma – Asthma is a chronic condition that affects the airways in the lungs, causing them to become inflamed and narrow. This leads to symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The severity and frequency of these symptoms can vary from person to person. Asthma can be triggered by various factors, including allergens, exercise, cold air, and stress. Over time, repeated asthma attacks can lead to changes in the airways, making them more sensitive and reactive. Managing asthma involves avoiding triggers and monitoring symptoms to maintain control over the condition.