Treatments for prolonged cough in children

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

It tests whether an inhaled steroid helps children with dry prolonged cough and whether an antibiotic helps children with wet prolonged cough compared with placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 1 Year to 6 Years
• Sex: All
• Sponsor: Tampere University Hospital (Academic / other)
• Locations: 1 site (Tampere)
• Trial ID: NCT07582549 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children who have had a daily cough for more than four weeks, are otherwise generally healthy with no identified cause on routine examinations, and whose parents can give written informed consent in Finnish are eligible.

Not a fit: Children with a known underlying disease explaining the cough, chronic conditions requiring continuous medication, prior severe allergy to fluticasone or amoxicillin–clavulanate, or concurrent participation in another drug trial are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the treatments could shorten cough duration for affected children and help avoid unnecessary medications.

How similar studies have performed: Previous studies and reviews have produced mixed or limited evidence for inhaled steroids and antibiotics in prolonged pediatric cough, so this trial addresses an unresolved clinical question.

Eligibility criteria

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 this trial is running

Tampere

• 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)

Conditions Chronic Cough; Child; Fluticasone Propionate; Amoxicillin-Potassium Clavulanate Combination; Randomized Controlled Trial; Double-Blind Method; Phase III