Finnish Children´s Protracted Cough
ConditionChronic Cough
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-6
SponsorTampere University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Fluticasone propionate inhalation
- Amoxicillin-clavulanic acid oral suspension
- Placebo inhalation
- Placebo oral suspension
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov