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Study on Salbutamol and Ipratropium Bromide for Treating Moderate Asthma Attacks in Children

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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 acute asthma in children who experience moderate asthma attacks. The study will compare two treatments: one using only salbutamol, a medication that helps open the airways in the lungs, and another using a combination of salbutamol and ipratropium bromide, which is another medication that helps relax and open the airways.

The purpose of the study is to determine if using only salbutamol is as effective as using both salbutamol and ipratropium bromide in managing moderate asthma attacks in children. The study will involve children who are treated in the emergency department for their asthma symptoms. Some children will receive the salbutamol treatment, while others will receive the combination treatment. There will also be a group receiving a placebo, which is a treatment with no active medication, to help compare the effects of the actual medications.

Throughout the study, the children will be monitored to see how well each treatment works in reducing the need for hospital admissions due to asthma attacks. The study aims to provide valuable information on the best treatment approach for managing moderate asthma attacks in children, helping to improve care and outcomes for young patients with asthma.

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
Enrollment and consent
Upon joining the study, the patient or their legal guardian will provide written informed consent. For patients aged 12 years or older, assent is also required.
The patient must be between 1 and 18 years old and experiencing a moderate asthma attack, as defined by specific medical criteria.
Step 2
Randomization
The patient will be randomly assigned to one of two treatment groups. This process ensures that each patient has an equal chance of receiving either treatment option.
Step 3
Treatment administration
The patient will receive treatment through inhalation. The treatment options include either salbutamol alone or a combination of salbutamol and ipratropium bromide.
The specific dosage and frequency of administration will be determined by the study protocol and administered in the pediatric emergency department.
Step 4
Monitoring and evaluation
The patient's response to the treatment will be closely monitored. This includes assessing the effectiveness of the treatment in managing the asthma attack.
The primary goal is to determine if the treatment with salbutamol alone is as effective as the combination treatment in reducing the need for hospital admission.
Step 5
Follow-up
After the initial treatment and monitoring, the patient may be required to attend follow-up visits to assess their ongoing health and any potential side effects of the treatment.
The duration of the follow-up period will be specified by the study protocol.

Who can join the trial?

5 criteria

Patient must be a boy or girl who is at least 1 year old but younger than 18 years old.
Patient must have a moderate asthma attack. This is a specific level of asthma severity measured by a tool called the Pulmonary Score.
The asthma attack must be classified according to the International Classification of Diseases version 10 (ICD10) and the Global Initiative for Asthma (2024 update).
Parents or legal guardians must provide written informed consent for the patient to participate in the study.
Patients who are 12 years old or older must also give their assent, which means they agree to participate.

Who cannot join the trial?

2 criteria

Patients with **severe asthma attacks** cannot participate. Only those with **moderate asthma attacks** are eligible.
Patients experiencing an **asthmatic crisis** or **exacerbation** that is not considered moderate are excluded. An exacerbation is a worsening of asthma symptoms.

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Verified sites

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Virgen del Rocío University Hospital
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Sevilla, Spain

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Investigated drugs

Salbutamol
is a medication used to help open up the airways in the lungs, making it easier to breathe. It is often used to treat asthma symptoms, such as wheezing and shortness of breath. In this trial, salbutamol is being tested to see how well it works on its own in treating moderate asthma attacks in children.
Ipratropium Bromide
is another medication that helps to open the airways in the lungs. It works differently from salbutamol and is often used together with it to provide better relief from asthma symptoms. In this trial, ipratropium bromide is combined with salbutamol to see if the combination is more effective than using salbutamol alone for treating moderate asthma attacks in children.

Ipratropium Bromide Monohydrate

What is already known about the treatment

Salbutamol
Salbutamol is administered as an inhaler, which allows the medication to be delivered directly to the lungs. It is currently well-established in medical practice and literature as a treatment for asthma. The main therapeutic use of salbutamol is to relieve symptoms of asthma, such as wheezing and shortness of breath, during an asthma attack. At the molecular level, salbutamol works by relaxing the muscles in the airways, making it easier to breathe. It is classified as a bronchodilator, which means it helps open up the air passages in the lungs.
Ipratropium Bromide
Ipratropium bromide is also administered via an inhaler, targeting the lungs directly. It is recognized in medical literature as a treatment for respiratory conditions like asthma. The primary use of ipratropium bromide is to help manage asthma symptoms by preventing the muscles around the airways from tightening. On a molecular level, it blocks certain receptors in the lungs, leading to the relaxation of airway muscles. It is classified as an anticholinergic bronchodilator, which helps to open the airways and make breathing easier.

Investigated diseases

Asthma, Acute – Acute asthma is a sudden worsening of asthma symptoms due to the tightening of muscles around the airways, known as bronchospasm. This condition leads to swelling and inflammation of the airways, causing them to narrow. It is characterized by difficulty breathing, wheezing, coughing, and shortness of breath. The severity of an acute asthma attack can vary, with moderate attacks being defined by specific clinical scores and oxygen saturation levels. During an exacerbation, the airways become more sensitive and reactive to various triggers. The progression involves increased airway resistance and reduced airflow, which can lead to significant respiratory distress if not managed promptly.