Prolonged cough lasting more than four weeks is common in children, but the best treatment is often unclear when no underlying disease can be found. This study aims to find out whether commonly used treatments help children with prolonged cough more effectively than placebo.
Children who take part will first undergo standard medical examinations, including lung function tests and a chest X-ray, to look for the cause of the cough. If no specific cause is found, the child may enter the study.
Children with a dry cough will be randomly assigned to receive either an inhaled corticosteroid (fluticasone) or a placebo inhaler for two months. Children with a wet or productive cough will be randomly assigned to receive either an oral antibiotic (amoxicillin-clavulanic acid) or a placebo medicine for 14 days. Neither the families nor the researchers will know which treatment the child receives during the study.
The main goal is to determine whether these treatments significantly reduce or stop the cough compared with placebo. The results will help improve treatment recommendations for children with prolonged cough and avoid unnecessary medication use.
Participation is voluntary, and parents provide written informed consent for their child.
Who can participate
Age range
1 Year – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Prolonged cough lasting continuously for more than 4 weeks
* No chronic disease requiring continuous medication (i.e. a generally healthy child)
* No previous physician-diagnosed condition associated with prolonged cough episodes
* No physician-identified symptoms or findings suggestive of an underlying disease
* No prior physician-diagnosed allergic reaction or other severe or life-threatening adverse reaction to the investigational medicinal products (fluticasone or amoxicillin-clavulanic acid)
* No simultaneous participation in another clinical drug trial
* Parents/guardians have sufficient spoken and written Finnish language proficiency
* Written, voluntary informed consent provided by a parent or legal guardian
Exclusion Criteria:
Children with symptoms or findings suggestive of an underlying cause of cough, including:
* A previously physician-diagnosed disease associated with prolonged cough
* Clinical examination or history at the study visit raising suspicion of a disease associated with prolonged cough (positive "cough pointers")
* Abnormal lung function test
* Abnormal chest X-ray (peribronchial markings are permitted)
Additional exclusion criteria:
* Prior physician-diagnosed allergic reaction or other severe or life-threatening adverse reaction to the investigational medicinal products
* Simultaneous participation in another clinical drug trial
* Prolonged cough that has resolved spontaneously prior to the study visit
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Significant cough resolution
Timeframe: Immediately after the intervention (2 months or 2 weeks from baseline depending on treatment arm)