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Finnish Children´s Protracted Cough
Sponsor: Tampere University Hospital
Summary
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.
Official title: A Randomized, Double-blinded Clinical Trial Comparing the Efficacy of Antibiotic or Inhaled Corticosteroid to Placebo in Children´s Protracted Cough
Key Details
Gender
All
Age Range
1 Year - 6 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-12-22
Completion Date
2027-12
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
Fluticasone propionate inhalation
Fluticasone propionate 125 micrograms (Trade name: Flixotide Evohaler) Administration (all ages): 125 micrograms (1 puff) twice daily via spacer Duration of treatment: 2 months
Amoxicillin-clavulanic acid oral suspension
Amoxicillin-clavulanic acid oral suspension 80/11.4 mg/ml Cream-white, sweet-tasting suspension Administration: Oral, weight-adjusted dosing 50 mg/kg/day divided into two equal doses Duration of treatment: 2 weeks
Placebo inhalation
Evohaler training inhaler 1. puff twice daily via spacer Duration of treatment: 2. months
Placebo oral suspension
Syrspend oral suspension base thickened with microcrystalline cellulose, without active pharmaceutical ingredient, administered with the same weight-adjusted regimen. Duration of treatment: 2 weeks
Locations (1)
Study Site: Tampere University Hospital (TAYS), Children's and Adolescents' Hospital Outpatient Paediatrics Unit P.O. Box 2000, FI-33521 Tampere, Finland
Tampere, Finland