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Finnish Children´s Protracted Cough

NCT07582549 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-13

No results posted yet for this study

Summary

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

  • Chronic Cough

Interventions

DRUG

Placebo oral suspension

Syrspend oral suspension base thickened with microcrystalline cellulose, without active pharmaceutical ingredient, administered with the same weight-adjusted regimen. Duration of treatment: 2 weeks

DRUG

Fluticasone propionate inhalation

Fluticasone propionate 125 micrograms (Trade name: Flixotide Evohaler) Administration (all ages): 125 micrograms (1 puff) twice daily via spacer Duration of treatment: 2 months

DRUG

Amoxicillin-clavulanic acid oral suspension

Amoxicillin-clavulanic acid oral suspension 80/11.4 mg/ml Cream-white, sweet-tasting suspension Administration: Oral, weight-adjusted dosing 50 mg/kg/day divided into two equal doses Duration of treatment: 2 weeks

DRUG

Placebo inhalation

Evohaler training inhaler 1. puff twice daily via spacer Duration of treatment: 2. months

Sponsors & Collaborators

  • Tampere University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07582549 on ClinicalTrials.gov