drugset / Trial / NCT07582549

Finnish Children´s Protracted Cough

NCT07582549

Phase 3 Recruiting 100 enrolled Tampere University Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-12-22
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 25 mg/kg Oral
Comparator Fluticasone propionate Other / unclassified 125 ug Inhaled

Indications

No indication recorded.