Finnish Children´s Protracted Cough

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Cough

In brief

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.

Key facts

Study ID

NCT07582549

Run by

Tampere University Hospital

People needed

100

Starts

2025-12-22

Expected to finish

2027-12-01

Last updated by the study team

2026-05-13

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• No prior physician-diagnosed allergic reaction or other severe or life-threatening adverse reaction to the investigational medicinal products (fluticasone or amoxicillin-clavulanic acid)
• No simultaneous participation in another clinical drug trial
• Parents/guardians have sufficient spoken and written Finnish language proficiency
• Written, voluntary informed consent provided by a parent or legal guardian

You may not qualify if…

• Children with symptoms or findings suggestive of an underlying cause of cough, including:
• 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)
• Additional exclusion criteria:
• Prior physician-diagnosed allergic reaction or other severe or life-threatening adverse reaction to the investigational medicinal products
• Simultaneous participation in another clinical drug trial
• Prolonged cough that has resolved spontaneously prior to the study visit

Where it is running

• Study Site: Tampere University Hospital (TAYS), Children's and Adolescents' Hospital Outpatient Paediatrics Unit P.O. Box 2000, FI-33521 Tampere, Finland — Tampere, Finland (enrolling)

Full record on ClinicalTrials.gov

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