A Randomized, Double-blinded Clinical Trial Comparing the Efficacy of Antibiotic or Inhaled Corticosteroid to Placebo in Children’s Protracted Cough

What this Trial Is About

Researchers are investigating treatments for prolonged cough lasting more than four weeks in children aged 1 to 6 years without an identifiable underlying disease. The study aims to determine whether commonly used medications, such as inhaled corticosteroids or antibiotics, are more effective than placebo in reducing or stopping the cough. This is a randomized, double-blind, placebo-controlled clinical trial designed to provide clear evidence to improve treatment recommendations and reduce unnecessary medication use. Children with a dry cough are randomly assigned to receive either an inhaled corticosteroid called fluticasone or a placebo inhaler for two months. Children with a wet or productive cough are randomly assigned to receive either an oral antibiotic, amoxicillin-clavulanic acid, or a placebo suspension for 14 days. Neither the families nor the researchers know which treatment the child receives during the study to ensure unbiased results. Participants undergo thorough medical assessments including lung function tests and chest X-rays before joining. During the study, researchers track cough severity and symptom changes using diaries and questionnaires. The main measurement is whether the cough stops or reduces by at least 75% for several days after treatment. Families can contact the study team anytime, and participation is voluntary and does not affect future medical care. The total participation depends on the treatment group, lasting two weeks or two months.

Finnish Children´s Protracted Cough