Recruiting

Study on Betamethasone Sodium Phosphate to Prevent Asthma in Children with First-time Rhinovirus-induced Wheezing

Fast replyRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on children who have experienced their first episode of severe wheezing, which is a type of breathing difficulty often associated with a viral infection called rhinovirus. The study aims to explore whether a treatment using a type of medication known as systemic corticosteroids can help prevent future episodes of wheezing and the development of asthma. The specific medication being tested is called dexamethasone, and it will be compared to a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to determine if these corticosteroids can effectively reduce the risk of recurrent wheezing and asthma in young children. Participants in the study will receive either the dexamethasone treatment or a placebo. The study will monitor the children over a period of time to see how many experience new episodes of wheezing or develop asthma, which is a condition that causes the airways to become inflamed and narrow, making it difficult to breathe.

Throughout the study, researchers will also observe other factors such as the duration and severity of any breathing difficulties, the children's overall quality of life, and their growth in terms of height and weight. This information will help determine the effectiveness of the treatment in preventing asthma and improving the health outcomes for children who have had a severe wheezing episode due to rhinovirus.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The child must be between 3 to 24 months old and experiencing their first severe wheezing episode. This episode should have started less than 7 days ago and be accompanied by symptoms such as fever, low oxygen levels, or difficulty breathing.
A test will confirm the presence of a rhinovirus infection. Consent for participation and cooperation in the study must be documented.
Step 2
Medication administration
The child will receive either a placebo tablet or a tablet containing dexamethasone, a type of steroid. The dosage and frequency will be determined by the study protocol.
Step 3
Monitoring and follow-up
The child will be monitored for any new episodes of wheezing or the development of asthma. This includes regular follow-up visits over a period of 24 months.
During these visits, the duration and severity of any breathing difficulties will be assessed, along with the child's lung reactivity, quality of life, and growth in terms of height and weight.
Step 4
Evaluation of outcomes
The primary outcomes being measured are the time until a new wheezing episode occurs and the time until asthma criteria are met, which would require regular asthma medication.
Secondary outcomes include the severity and duration of symptoms during any breathing difficulties and overall health and development indicators.

Who can join the trial?

9 criteria

The child must be between the ages of 3 to 24 months.
The child must be experiencing their first episode of severe wheezing. This means it's the first time they have had serious trouble breathing with a wheezing sound, and it started less than 7 days ago.
The child must have been referred to a hospital and show one or more of the following signs:
- Fever: A higher than normal body temperature.
- Hypoxia: Low oxygen levels in the blood, with a saturation of oxygen (SAT O2) of 92% or less.
- Retractions: The skin between or under the ribs pulls in during breathing.
- Prolonged expiration: Longer than normal time to breathe out, noticed by listening to the chest.
- Expiratory rhonchi: A rattling sound heard when breathing out, noticed by listening to the chest.
- There must be evidence of a rhinovirus infection, confirmed by a PCR test on a sample from the nose or throat.
- A signed informed consent must be obtained. This means the parents or guardians agree to the child's participation and understand what the study involves.

Who cannot join the trial?

5 criteria

Children who have had wheezing or bronchiolitis before cannot participate.
Children who do not have a rhinovirus infection cannot participate. Rhinovirus is a common virus that causes colds.
Children who are not experiencing their first severe wheezing episode cannot participate.
Children who are not within the specified age range for the study cannot participate.
Children who are not able to take systemic corticosteroids cannot participate. Systemic corticosteroids are medicines that help reduce inflammation in the body.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Akershus University Hospital
Verified
Lorenskog, Norway
Helse Bergen HF
Verified
Bergen, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Systemic Corticosteroids are medications used in this trial to help reduce inflammation in the airways. They are being tested to see if they can prevent children who have had a severe wheezing episode caused by a rhinovirus infection from developing recurrent wheezing or asthma. These medications work by calming down the immune system and reducing swelling in the airways, making it easier to breathe.

Betamethasone Sodium Phosphate

What is already known about the treatment

Systemic Corticosteroids – These medications are typically administered orally or through injection. They are currently being studied for their potential to prevent recurrent wheezing and asthma in children who experience severe wheezing due to a rhinovirus infection. The main therapeutic indication is to reduce the risk of developing asthma after an initial wheezing episode. At the molecular level, corticosteroids work by reducing inflammation and suppressing the immune response, which helps to decrease airway swelling and mucus production. They belong to the pharmacological class of anti-inflammatory agents.

Investigated diseases

Acute Wheezing/Bronchiolitis – This condition is characterized by a sudden onset of wheezing and difficulty breathing, often seen in young children. It is typically caused by viral infections, such as the rhinovirus, which leads to inflammation and congestion in the small airways of the lungs. Symptoms may include rapid breathing, coughing, and a whistling sound when exhaling. The condition can vary in severity, with some children experiencing mild symptoms and others having more severe breathing difficulties. It often occurs in episodes, and children may have recurrent episodes over time. The progression of the disease can lead to further respiratory issues if not managed properly.