Kids' cough study: antibiotics or steroids – placebo may be just as good
NCT ID NCT07582549
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether two common treatments—an inhaled steroid (fluticasone) for dry cough and an antibiotic (amoxicillin-clavulanic acid) for wet cough—actually help children with a cough lasting more than four weeks. About 100 generally healthy children will be randomly assigned to receive the real treatment or a placebo, and neither families nor doctors will know which. The goal is to see if these treatments significantly reduce or stop the cough compared to placebo, which could improve treatment guidelines and avoid unnecessary medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fluticasone propionate (inhaled corticosteroid) or amoxicillin-clavulanic acid (antibiotic)
- What this could lead to
- If successful, this could provide clear evidence on whether common treatments like inhaled steroids or antibiotics actually help children with persistent cough, reducing unnecessary medication use.
- What could go wrong
- This is a relatively small trial (100 children) and results may not apply to all kids. The treatments may not work better than placebo, and side effects like allergic reactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 6 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Study Site: Tampere University Hospital (TAYS), Children's and Adolescents' Hospital Outpatient Paediatrics Unit P.O. Box 2000, FI-33521 Tampere, Finland
RECRUITINGTampere, Finland
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