Recruiting

Study on Extending Dosing Intervals of Mepolizumab and Dupilumab for Patients with Severe 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 treatments for severe asthma, a condition where the airways in the lungs become inflamed and narrow, making it difficult to breathe. The study involves two medications: Dupixent (also known as dupilumab) and Nucala (also known as mepolizumab). Dupixent is given as a solution for injection in a pre-filled syringe, while Nucala is a powder that is mixed into a solution for injection. Both medications are administered through a subcutaneous injection, which means they are injected under the skin.

The purpose of the study is to see if the time between doses of these medications can be safely extended without losing control over asthma symptoms. For patients with severe eosinophilic asthma, the study will look at extending the dosing interval of mepolizumab based on levels of a type of white blood cell called eosinophils. For those with severe T2-high asthma, the study will evaluate extending the dosing interval of dupilumab based on levels of a biomarker called FeNO, which is a measure of inflammation in the airways.

Participants in the study will receive either mepolizumab or dupilumab over a period of up to 12 months. The study will monitor the number of injections each participant receives during the follow-up period. This research aims to improve the management of severe asthma by potentially reducing the frequency of medication doses while maintaining effective control of the disease.

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
Joining the trial
Upon joining the BIRDIE trial, the focus is on evaluating the possibility of extending the dosing interval of two medications: mepolizumab and dupilumab.
These medications are used for treating severe asthma, specifically targeting eosinophilic and T2-high asthma types.
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility, which includes having severe asthma as the primary indication for treatment with either mepolizumab or dupilumab for the last 6 months.
Asthma must be stable, with an Asthma Control Questionnaire (ACQ) score of less than 1.5 and no severe exacerbations for at least 6 months.
Step 3
Medication administration
Mepolizumab is administered as a subcutaneous injection every 4 weeks, while dupilumab is administered every 2 weeks.
The trial aims to determine if the interval between doses can be extended without losing asthma control.
Step 4
Monitoring and follow-up
Regular monitoring of asthma control is conducted, focusing on biomarkers such as eosinophil levels for mepolizumab and FeNO levels for dupilumab.
The main endpoint of the study is the number of injections received during the follow-up period.
Step 5
Trial duration
The trial is expected to continue until September 2026, with recruitment having started in September 2023.
Participants will be involved in the study for the duration necessary to evaluate the primary endpoints.

Who can join the trial?

5 criteria

The patient must have **severe asthma** as the main reason for treatment with either mepolizumab (one dose every 4 weeks) or dupilumab (one dose every 2 weeks) for the past 6 months.
The patient's asthma must be **stable**, meaning they have an **Asthma Control Questionnaire (ACQ)** score of less than 1.5 and have not had any severe asthma attacks for at least 6 months.
The patient must have a good understanding of the Dutch language.
Both male and female patients can participate.
The study is not intended for vulnerable populations.

Who cannot join the trial?

4 criteria

Patients with other types of asthma that are not classified as severe asthma cannot participate. Severe asthma is a type of asthma that is difficult to control and requires high doses of medication.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.
Patients who do not meet the specific health criteria required for the study cannot participate. This includes having certain medical conditions or health issues that are not compatible with the study requirements.

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Verified sites

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Sint Franciscus Vlietland Groep Stichting
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Rotterdam, The Netherlands

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Investigated drugs

Mepolizumab
is a medication used in this trial to treat patients with severe eosinophilic asthma. The trial aims to see if the time between doses can be extended by monitoring eosinophil levels, which are a type of white blood cell involved in asthma. The goal is to maintain asthma control while reducing the frequency of medication administration.
Dupilumab
is another medication involved in the trial, used for patients with severe T2-high asthma. The study investigates whether the dosing interval can be extended by using FeNO (fractional exhaled nitric oxide) levels as a biomarker. This approach aims to keep asthma symptoms under control while potentially reducing how often the medication needs to be taken.

What is already known about the treatment

Mepolizumab
Mepolizumab is administered as an injection under the skin. It is currently being studied in clinical trials to determine if the dosing interval can be extended for patients with severe eosinophilic asthma, using eosinophil levels as a biomarker. This medication is primarily used to treat severe asthma by targeting and inhibiting interleukin-5 (IL-5), a protein that plays a key role in the growth and activation of eosinophils, which are inflammatory cells involved in asthma. Mepolizumab is classified as a monoclonal antibody.
Dupilumab
Dupilumab is given as an injection under the skin. It is under investigation in clinical trials to assess whether the dosing interval can be extended for patients with severe T2-high asthma, using FeNO levels as a biomarker. This medication is mainly used for severe asthma and works by blocking the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are proteins involved in the inflammatory response. Dupilumab is classified as a monoclonal antibody.

Investigated diseases

Severe Asthma – Severe asthma is a chronic respiratory condition characterized by frequent and intense symptoms such as wheezing, shortness of breath, chest tightness, and coughing. It involves inflammation and narrowing of the airways, making it difficult to breathe. Unlike mild or moderate asthma, severe asthma does not respond well to standard treatments and requires more intensive management. The condition can be triggered by allergens, respiratory infections, exercise, or stress. Over time, severe asthma can lead to persistent airway changes and reduced lung function. It often requires ongoing monitoring and adjustments in treatment to maintain control over symptoms.