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RECRUITING
NCT07582549
PHASE3

Finnish Children´s Protracted Cough

Sponsor: Tampere University Hospital

View on ClinicalTrials.gov

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

DRUG

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

DRUG

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

DRUG

Placebo inhalation

Evohaler training inhaler 1. puff twice daily via spacer Duration of treatment: 2. months

DRUG

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