Study on Adjusting Omalizumab Dosage for Patients with Severe Allergic Asthma

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Consorci Mar Parc De Salut De Barcelona	Barcelona	Spain
Izaaycabc Dz Iexrxcoervply En Crvanrwn De Ly Sesxh Gxntwzn Tmuql I Pkbgx	Barcelona	Spain
Hkydruku Vldw dxebsbjn	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	09.03.2022

Trial locations

Investigated drugs:

Omalizumab

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.

Investigated diseases:

Asthma

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.

Trial ID:

2025-520782-48-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Adjusting Omalizumab Dosage for Patients with Severe Allergic Asthma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?