Treatments for prolonged cough in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children with a cough lasting more than four weeks receive standard clinical screening including lung function tests and a chest X-ray; if no clear cause is found they may enter the trial. Those with a dry cough are randomized to receive inhaled fluticasone or a matching placebo for two months, while those with a wet productive cough are randomized to receive oral amoxicillin–clavulanate or matching placebo for 14 days. The trial is double-blind so neither families nor researchers know which treatment a child receives. The main outcome is whether these commonly used treatments reduce or stop the prolonged cough compared with placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

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's 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 Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.