Actively Recruiting

Phase 3
Age: 1Year - 6Years
All Genders
NCT07582549

Finnish Children´s Protracted Cough

Led by Tampere University Hospital · Updated on 2026-05-13

100

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Finnish Children´s Protracted Cough

Who Can Participate

Age: 1Year - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cough lasting continuously for more than 4 weeks
  • Generally healthy child with no chronic disease requiring continuous medication
  • No previous doctor-diagnosed condition linked to prolonged cough
  • No symptoms or findings suggesting underlying disease
  • No prior severe allergic or life-threatening reaction to study medications (fluticasone or amoxicillin-clavulanic acid)
  • Not participating in another clinical drug trial
  • Parents or guardians able to speak and write Finnish
  • Written informed consent provided by parent or legal guardian
Not Eligible

You will not qualify if you...

  • Symptoms or findings suggesting an underlying cause of cough
  • Previous doctor-diagnosed disease linked to prolonged cough
  • Abnormal lung function test
  • Abnormal chest X-ray (except allowed peribronchial markings)
  • Prior severe allergic or life-threatening reaction to study medications
  • Participation in another clinical drug trial
  • Cough resolved spontaneously before study visit

AI-Screening

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Trial Site Locations

Total: 1 location

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

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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