AuthorisedTherapeutic use (Phase IV)Interventional

Therapheutic optimization of omalizumab in allergic severe asthma patients by dose and frequency of administration adjustment

This study is for adults who have severe asthma caused by allergies and are already taking a medication called Xolair (omalizumab). The main goal is to find out if reducing the dose of Xolair by half still helps people control their asthma effectively. Researchers will be checking if patients have fewer asthma attacks, how their quality of life is, and how well their lungs are working. This is a "Phase IV" study, which means it's looking at how a treatment already in use can be given in a better way. If a lower dose works just as well, it could mean less medication for patients while keeping their asthma under control.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Consorci Mar Parc De Salut De Barcelona

Enrolment target

110

Start

30 Jan 2025

Asthma

What is this study about?

This study is investigating a new way to use a medicine called Xolair (omalizumab) for people with severe allergic asthma. If you have this type of asthma, it means your asthma is triggered by things you are allergic to, like pollen or dust mites, and it can be quite severe. Xolair is an injection that helps to reduce these allergic reactions, making your asthma easier to manage.

The main idea behind this study is to see if patients who are already doing well on Xolair can take a lower dose of the medication. Specifically, they want to test if taking half the usual dose of Xolair still provides the same good level of asthma control. This is important because finding the lowest effective dose can be better for patients in the long run.

To figure this out, researchers will be carefully observing people in the study. They will look at whether participants have fewer asthma attacks (crises), how their overall quality of life is affected, and how well their lungs are working. This type of study, called a Phase IV trial, often looks at how existing treatments can be used in the most effective and safe way in a real-world setting. If successful, it could mean a simpler and equally effective treatment plan for many people with severe allergic asthma.

Key takeaways

Study for adults with severe allergic asthma.
Investigating if a lower dose of Xolair (omalizumab) works as well as a higher dose.
Will assess asthma attacks, quality of life, and lung function.
Aims to find the best way to use existing asthma medication.
Participants must be 18 years or older.

Who may be eligible?

This study is looking for adults aged 18 and over who have severe asthma caused by allergies. You would need to be currently taking Xolair (omalizumab) to control your asthma.

Both men and women can take part in this research. The study needs participants who are already stable on their current Xolair treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe asthma caused by allergies?
Are you currently taking Xolair (omalizumab) for your asthma?
Are you generally stable on your current Xolair treatment?

Answer every question to see your result.

What does participation involve?

The detailed information about taking part isn't available, but generally in studies like this, you would continue to receive your Xolair medication, possibly at a reduced dose, under careful medical supervision. You would likely have regular clinic visits where doctors and nurses would check your asthma symptoms, lung function (often with breathing tests), and overall health. You might also be asked to complete questionnaires about your quality of life and any asthma attacks you experience.

These visits help the research team understand if the changed dose is working as well as your previous dose. The total duration of your participation would depend on the study design, but typically such follow-ups occur over several months to a year or more. All aspects of your health and asthma control would be monitored closely throughout the study.

Potential risks and benefits

Potential benefits of taking part could include gaining a better understanding of how your asthma responds to a lower dose of medication. If the lower dose is effective, it might mean you need less medication in the future. Potential risks, as with any medication or change in dose, could include your asthma symptoms worsening slightly while on the reduced dose, though you would be closely monitored by medical professionals. There is always the chance the new dosing strategy might not work for you. Remember, you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is severe allergic asthma?

It's a type of asthma that is very serious and is triggered by things you're allergic to, like pollen, dust, or pet dander.

What is Xolair (omalizumab)?

Xolair is a medicine given by injection that helps reduce the allergic reactions that cause asthma symptoms.

Why reduce the dose?

Researchers want to see if taking less medication can still give you the same good asthma control, which could be better for you in the long run.

What will the study check?

They will check for asthma attacks, your quality of life, and how well your lungs are working to see if the lower dose is effective.

Is this a new medicine?

No, Xolair is already used. This study is looking at the best way to use it, like if a lower dose works just as well.