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Finnish Children´s Protracted Cough

RecruitingPhase 3Ages 1 Year - 6 YearsAllTampere University Hospital
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In plain words

What the trial is, and whether it could suit you

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 d

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • Fluticasone propionate inhalation
  • Amoxicillin-clavulanic acid oral suspension
  • Placebo inhalation
  • Placebo oral suspension
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Where

1 site
Study Site: Tampere University Hospital (TAYS), Children's and Adolescents' Hospital Outpatient Paediatrics Unit P.O. Box 2000, FI-33521 Tampere, Finland
Tampere, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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