Finnish Children´s Protracted Cough

NCT07582549 | Recruiting Phase 3 DMC

• 1 other identifier: 2025-520697-19-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Significant cough resolution

  Significant reduction in cough, defined as: complete resolution, or ≥75% reduction in symptom score compared with baseline for three consecutive days

  Immediately after the intervention (2 months or 2 weeks from baseline depending on treatment arm)

Secondary Outcomes (7)

• Time to earliest significant reduction or resolution of cough.

  Immediately after the intervention

• Mean cough symptom diary scores before treatment intervention

  Baseline

• Mean cough symptom diary scores during intervention

  7 and 14 days (productive/wet cough), and 2, 4, 6, and 8 weeks (dry cough) from baseline

• Change in cough symptom scores

  Immediately after the intervention

• Change in cough severity

  Immediately after the intervention

Other Outcomes (11)

• Underlying conditions

  Baseline

• Asthma identified at the study visit

  Baseline

• Specific cause (diagnosis) of prolonged cough identified

  Baseline

Study Arms (2)

Dry cough

ACTIVE COMPARATOR

Fluticasone propionate inhalation

Drug: Fluticasone propionate inhalation; Drug: Placebo inhalation

Productive (Wet) Cough

ACTIVE COMPARATOR

Amoxicillin-clavulanic acid oral suspension

Drug: Amoxicillin-clavulanic acid oral suspension; Drug: Placebo oral suspension

Interventions

Fluticasone propionate inhalation DRUG

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

Dry cough

Amoxicillin-clavulanic acid oral suspension DRUG

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

Productive (Wet) Cough

Placebo inhalation DRUG

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

Dry cough

Placebo oral suspension DRUG

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

Productive (Wet) Cough

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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)
• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (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

RECRUITING

Related Links

• Project website

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled parallel-group clinical trial, stratified by cough type (dry vs wet)

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 13, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)