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Study on the Effectiveness and Safety of Indacaterol Acetate/Mometasone Furoate vs. Budesonide for Children Aged 6-11 with 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 treatment of asthma in children aged 6 to less than 12 years. The study will compare the effectiveness and safety of a medication called QMF149, which contains two active ingredients: indacaterol acetate and mometasone furoate, against another medication known as budesonide. The purpose of the study is to determine if QMF149 is better at improving lung function in children with asthma.

Participants in the study will receive treatment over a period of 12 weeks. During this time, they will use an inhalation device called a Breezhaler to take their medication. The study will involve two treatment periods, and each child will receive both QMF149 and budesonide at different times. The study will also include a placebo, which is a capsule that looks like the medication but does not contain any active ingredients. The main goal is to see how well the medications improve lung function, measured by a test called FEV1, which checks how much air a person can exhale in one second.

In addition to lung function, the study will monitor other aspects of asthma, such as symptoms, peak air flow, and the number of asthma flare-ups. The use of rescue medication, which is taken when asthma symptoms worsen, will also be tracked. Safety assessments will be conducted throughout the study to ensure the well-being of the participants. This includes checking for any side effects through clinical assessments, laboratory tests, and heart monitoring using ECGs (electrocardiograms).

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, you will be assigned to one of two treatment groups. This assignment is random, meaning it is like flipping a coin to decide which group you will be in.
You will receive either QMF149 (a combination of indacaterol acetate and mometasone furoate) or budesonide. Both are medications used to help manage asthma symptoms.
Step 2
Treatment period
The study consists of two treatment periods, each lasting 12 weeks. During each period, you will use the assigned medication.
The medication is provided as an inhalation powder in a hard capsule form. You will use it through inhalation, which means breathing it into your lungs.
Step 3
Medication administration
You will take the medication as instructed by the study team. The dosage and frequency will be explained to you, ensuring you understand how to use the inhaler correctly.
It is important to follow the instructions carefully to ensure the effectiveness of the treatment.
Step 4
Monitoring and assessments
Throughout the study, your lung function will be monitored. This involves measuring how well your lungs are working, which is done using a test called FEV1 (forced expiratory volume in one second).
You will also be asked about your asthma symptoms and any changes you notice. This helps the study team understand how the medication is affecting you.
Step 5
End of each treatment period
At the end of each 12-week treatment period, your lung function and asthma symptoms will be evaluated again.
The study team will compare these results to your initial measurements to assess any improvements or changes.
Step 6
Safety assessments
Throughout the study, any side effects or unexpected reactions will be monitored closely. This is to ensure your safety while participating in the trial.
Regular check-ups, including clinical assessments and possibly lab tests or ECGs (a test that checks your heart's electrical activity), will be conducted.
Step 7
Completion of the trial
Once both treatment periods are completed, the study will conclude. The study team will review all the data collected to determine the effectiveness and safety of the medications.
You will be informed about the overall findings of the study and any next steps, if applicable.

Who can join the trial?

6 criteria

Children who are 6 to less than 12 years old.
Must have been diagnosed with asthma for at least 1 year before joining the study.
Asthma must not be well controlled with low-dose inhaled steroids. Inhaled steroids are medicines you breathe in to help control asthma.
If previously well controlled with a combination of low-dose steroids and additional medication, asthma must show poor control after the initial trial period when treated with a low-dose inhaled steroid called fluticasone propionate.
Must qualify for treatment with low-dose inhaled corticosteroids plus a long-acting beta agonist. A long-acting beta agonist is a type of medicine that helps open up the airways in the lungs.
Both boys and girls can participate.

Who cannot join the trial?

8 criteria

Patients who do not have a diagnosis of asthma.
Patients who are not within the specified age range for the study.
Patients who are not willing or able to follow the study procedures.
Patients who have other significant health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to provide informed consent.

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Verified sites

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

Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Verified
Naples, Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Verified
Catania, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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Investigated drugs

QMF149
is a combination of two medications used to help people with asthma breathe better. It includes indacaterol, which helps to relax and open the airways in the lungs, making it easier to breathe. The other component, mometasone, is a type of steroid that reduces inflammation in the airways, helping to prevent asthma symptoms like wheezing and shortness of breath. This combination is used to improve lung function in children with asthma.
Budesonide
is a medication that helps control and prevent asthma symptoms. It is a type of steroid that works by reducing inflammation in the airways, which helps to keep them open and makes breathing easier. Budesonide is used regularly to help prevent asthma attacks and improve overall lung function in children with asthma.

What is already known about the treatment

Indacaterol acetate / Mometasone furoate (QMF149) – This medication is administered as an inhalation, which means it is breathed directly into the lungs using an inhaler device. It is currently being studied in clinical trials for its effectiveness in treating asthma, particularly in children aged 6 to less than 12 years. The main purpose of this medication is to improve lung function by helping to open the airways and reduce inflammation, making it easier to breathe. Indacaterol works by relaxing the muscles around the airways, while mometasone reduces swelling and irritation in the airways. This combination is classified as a long-acting beta-agonist (LABA) and corticosteroid, which are commonly used in asthma management.

Investigated diseases

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The progression of asthma can vary, with some individuals experiencing mild symptoms and others having more severe episodes. Asthma symptoms 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. The condition requires ongoing management to control symptoms and prevent exacerbations.