Study on Azithromycin for Treating Hospitalized Children Aged 1-5 with Asthma Symptoms

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What is this study about?

This clinical trial is focused on studying the effects of the medication azithromycin on children aged 1-5 years who are hospitalized with symptoms similar to asthma. Asthma is a condition that affects the airways in the lungs, making it difficult to breathe. The purpose of the study is to see if a three-day treatment with azithromycin can reduce the duration of these asthma-like episodes compared to a placebo. The study aims to replicate previous findings that showed azithromycin could significantly shorten the length of these episodes.

During the trial, children will receive either azithromycin or a placebo for three days. The study will monitor how long the asthma-like symptoms last from the start of the treatment. It will also look at changes in symptom scores, the length of hospital stays, and the need for additional medications like short-acting beta-agonists (SABA) or oral corticosteroids (OCS). The study will also consider whether bacteria in the airways affect the results and assess the economic impact on families, such as days missed from daycare or work.

In addition to azithromycin, the study involves other substances like xanthum gum, sucrose, silica, colloidal anhydrous, aspartame, hydroxypropyl cellulose LF, sodium phosphate dodecahydrate, and titanium dioxide. These substances are used in various forms, such as creams, powders, and tablets, and are administered orally. The trial will help determine the effectiveness of azithromycin in treating asthma-like symptoms in young children and provide insights into the potential benefits and costs associated with this treatment approach.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the medication azithromycin or a placebo. This process is called randomization and ensures that the study results are unbiased.

2 medication administration

If you are assigned to the azithromycin group, you will receive the medication orally. The dosage and frequency will be determined by the study team, and you will take the medication for a period of three days.

If you are assigned to the placebo group, you will receive a substance that looks like the medication but does not contain the active ingredient. This is to compare the effects of the medication with no treatment.

3 monitoring and assessment

Throughout the study, your child’s symptoms will be closely monitored. This includes tracking the duration of the asthma-like episode from the start of the study.

You will be asked to keep a diary to record any changes in symptoms, which will help assess the effectiveness of the treatment.

4 hospitalization duration

The length of your child’s hospital stay will be recorded as part of the study. This information will help determine if the treatment affects the duration of hospitalization.

5 use of additional medications

The study will also track the need for additional medications, such as short-acting beta-agonists (SABA) or oral corticosteroids (OCS), during the asthma-like episode.

6 completion of the study

At the end of the study, all collected data will be analyzed to determine the effectiveness of azithromycin in treating asthma-like symptoms in children.

The study aims to provide insights into the potential benefits of the medication and its impact on the duration of asthma episodes.

Who Can Join the Study?

  • The child has had previous episodes with asthma-like symptoms and has been treated with SABA (a type of medication that helps open the airways) alone or with ICS (inhaled corticosteroids, which reduce inflammation in the airways) and possibly LTRA (a medication that helps prevent asthma symptoms).
  • The parent or guardian agrees to admit the child to the study and is willing to follow the study procedures.
  • The child is between 12 and 71 months old (1 to almost 6 years old).
  • The parents or guardians must be fluent in Danish.

Who Cannot Join the Study?

  • Children who are not between the ages of 1 and 5 years old cannot participate.
  • Children who are not hospitalized due to asthma-like symptoms cannot participate.
  • Children who are part of a vulnerable population cannot participate. A vulnerable population refers to groups who may have limited ability to protect their own interests, such as those with certain disabilities or conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Gentofte Hospital Hellerup Denmark
Acxyok Uvsaxtsdjv Hsxhdlzd Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
16.10.2024

Trial locations

Azithromycin is an antibiotic that is used to treat various types of infections caused by bacteria. In this clinical trial, azithromycin is being tested to see if it can help children aged 1-5 years who are hospitalized with asthma-like symptoms. The goal is to find out if taking azithromycin for three days can make the asthma episode shorter, helping the children recover faster. This study builds on previous research that showed positive results with azithromycin in similar situations.

Investigated diseases:

Childhood Asthma – Childhood asthma is a chronic inflammatory disease of the airways that affects children, causing them to become narrow and swollen. This condition leads to recurring periods of wheezing, chest tightness, shortness of breath, and coughing, particularly at night or early in the morning. The progression of childhood asthma can vary, with some children experiencing mild symptoms that occur infrequently, while others may have more severe and persistent symptoms. Triggers such as allergens, respiratory infections, physical activity, and changes in weather can exacerbate the symptoms. Over time, if not managed properly, the inflammation can lead to long-term damage to the airways. The condition often requires ongoing monitoring and management to prevent exacerbations and maintain quality of life.

Trial ID:
2024-512605-29-01
Protocol code:
COPSACazt
NCT ID:
NCT05028153
Trial Phase:
Therapeutic exploratory (Phase II)

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