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Study on the Effectiveness of Fluticasone Propionate and Amoxicillin-Clavulanic Acid for Children with Long-Lasting Cough

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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 children with a protracted cough, which is a cough that lasts for an extended period without any other underlying health issues. The study will evaluate the effectiveness of two treatments: an inhaled medication called Fluticasone Propionate, which is a type of corticosteroid, and an oral antibiotic known as Amoxicillin and Clavulanic Acid. These treatments will be compared to a placebo to see how well they work in reducing the cough.

The purpose of the study is to determine if these medications can help children who have a persistent dry or wet cough. Participants will be randomly assigned to receive either the inhaled corticosteroid, the oral antibiotic, or a placebo. The study will be conducted in a double-blinded manner, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This helps ensure that the results are unbiased and reliable.

Throughout the study, the children's cough symptoms will be monitored to see if there is a significant reduction in their cough. The study will last for a specific period, with the inhaled corticosteroid treatment lasting up to eight weeks and the oral antibiotic treatment lasting up to two weeks. The goal is to find out if these treatments can significantly reduce the cough symptoms in children compared to the placebo.

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
Joining the trial
Upon joining the trial, the participant will be randomly assigned to one of the study groups. This means that the participant will either receive the actual medication or a placebo, which is a substance with no active ingredients. The assignment is done randomly to ensure fairness and objectivity in the study results.
Step 2
Medication administration
Participants with a prolonged dry cough will receive an inhaled medication called fluticasone propionate. This medication is administered using a device called an inhaler. The inhaler delivers the medication directly to the lungs through inhalation. The dosage is 125 micrograms per dose, and it is taken as prescribed by the study team.
Participants with a prolonged wet cough will receive an oral antibiotic called amoxicillin, clavulanic acid. This medication is taken by mouth in the form of a suspension. The dosage and frequency will be provided by the study team and must be followed as instructed.
Step 3
Monitoring and follow-up
Throughout the trial, participants will be monitored for any changes in their cough symptoms. The primary goal is to observe a significant reduction in cough, defined as either the complete cessation of coughing or at least a 75% reduction in symptom scores compared to the initial assessment over three consecutive days.
Participants may be required to attend follow-up visits or provide updates on their symptoms as part of the study's monitoring process. These updates help the study team assess the effectiveness of the treatment.
Step 4
Completion of the trial
At the end of the trial, participants will have a final assessment to evaluate the overall effectiveness of the treatment they received. This assessment will help determine if the medication was successful in reducing the symptoms of a prolonged cough.
Participants will be informed about the results of the trial and any further steps if necessary. The study team will provide guidance on any additional care or treatment that may be needed after the trial concludes.

Who can join the trial?

7 criteria

The child must have a protracted cough that has lasted every day for more than 4 weeks.
The child must not have a previous diagnosis from a doctor that could explain the long-lasting cough.
The child must not have any symptoms or findings from a doctor that suggest another underlying condition causing the cough.
The child must not have had any previous allergic reactions or serious side effects to the study medications, which are fluticasone (a medication used to reduce inflammation) and amoxicillin-clavulanic acid (an antibiotic).
The child must not be participating in another medical study at the same time.
The parents must be able to speak and write in Finnish.
The parents must provide written voluntary consent for their child to participate in the study.

Who cannot join the trial?

3 criteria

Children with a **protracted cough** (a cough that lasts a long time) without other findings that suggest a disease causing the cough.
Children who are not in the age range specified for the study.
Children who are part of a vulnerable population.

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Pirkanmaan hyvinvointialue
Tampere, Finland

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Investigated drugs

Fluticasone
is a medication used in this trial as an inhaled corticosteroid. It helps reduce inflammation in the airways, making it easier to breathe. In this study, it is being tested to see if it can help children who have a long-lasting dry cough without any other signs of a more serious illness.
Amoxicillin-Clavulanic Acid
is an antibiotic used in this trial. It is taken by mouth and works by killing bacteria that can cause infections. In this study, it is being tested to see if it can help children who have a long-lasting wet cough without any other signs of a more serious illness.

What is already known about the treatment

Fluticasone
Fluticasone is administered as an inhaled medication, meaning it is breathed directly into the lungs using an inhaler device. It is currently being studied in clinical trials to assess its effectiveness in treating children with a prolonged dry cough. The main therapeutic use of fluticasone is to reduce inflammation in the airways, which can help alleviate coughing. At the molecular level, fluticasone works by binding to glucocorticoid receptors, which leads to a decrease in the production of inflammatory substances in the body. It is classified as an inhaled corticosteroid, a type of medication commonly used to manage respiratory conditions.
Amoxicillin-Clavulanic Acid
Amoxicillin-Clavulanic Acid is taken orally, usually in the form of a tablet or liquid, and is swallowed. It is being evaluated in clinical trials for its potential to treat children with a prolonged wet cough. This medication is primarily used as an antibiotic to fight bacterial infections. It works by inhibiting the growth of bacteria, with amoxicillin disrupting bacterial cell wall formation and clavulanic acid preventing bacterial resistance to amoxicillin. This combination is classified as a penicillin-type antibiotic, which is effective against a wide range of bacterial infections.

Investigated diseases

Protracted Cough – Protracted cough is a condition characterized by a cough that persists for an extended period, typically lasting more than four weeks in children. It can be either dry or productive, meaning it may or may not produce mucus. The cough is not associated with any underlying respiratory disease or other identifiable causes. It often results from prolonged inflammation or irritation of the airways. The condition can cause discomfort and disrupt daily activities, including sleep. Over time, the cough may gradually decrease in frequency and intensity.