Finnish Children´s Protracted Cough (FINNCHICO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Cough
• Intervention / Treatment: Drug: Fluticasone propionate inhalation; Drug: Placebo inhalation; Drug: Amoxicillin-clavulanic acid oral suspension; Drug: Placebo oral suspension

Detailed Description

Why is this study being done? A cough that lasts for more than four weeks is common in children and can be distressing for both the child and their family. In many cases, careful medical examinations do not reveal a clear underlying disease that would explain the symptoms. Despite this, children are often treated with medications such as inhaled corticosteroids or antibiotics, even though it is not always clear whether these treatments are truly beneficial.

The aim of this study is to find out whether two commonly used treatments are more effective than placebo in children with prolonged cough when no clear cause can be identified. By doing this, the study seeks to improve future care for children with prolonged cough and reduce unnecessary medication use.

Who is organising the study? The study is conducted by the Pirkanmaa Wellbeing Services County in Finland and led by an experienced paediatric specialist at Tampere University Hospital (TAYS). The research team specialises in children's respiratory diseases and follows national and international clinical research regulations.

Who can take part?

The study includes children who:

Have had a cough every day for more than four weeks Are otherwise generally healthy Do not have a previously diagnosed illness that could explain the cough

Before joining the study, all children undergo thorough and routine medical assessments to look for possible causes of the cough. These include a clinical examination, breathing tests, and a chest X-ray. Children whose cough can be explained by an underlying disease are not included in the study and will receive appropriate standard medical care outside the study.

Participation is completely voluntary. Parents or legal guardians must give written informed consent before a child can participate.

What treatments are studied?

Children are divided into two groups based on the type of cough they have:

1. Children with a dry cough

   These children receive either:

   An inhaled corticosteroid (fluticasone), which is commonly used to reduce airway inflammation, or A placebo inhaler, which looks and is used in the same way but contains no active medicine

   The treatment is taken twice daily for two months.

2. Children with a wet or productive cough

These children receive either:

An oral antibiotic (amoxicillin-clavulanic acid), often used to treat respiratory infections, or A placebo liquid, which looks and tastes similar but does not contain active medication

This treatment is taken for 14 days.

How is the study organised? This is a randomised, double-blind, placebo-controlled clinical trial, which is considered the most reliable way to study treatment effects.

This means:

Children are randomly assigned to receive either the active treatment or placebo Neither the families nor the researchers know which treatment a child receives during the study The treatments and placebos are designed to look and taste the same

These methods help ensure that the results are fair and unbiased.

What does the study measure?

The main outcome of the study is whether the child's cough:

Stops completely, or Decreases clearly (by at least 75%) compared with the start of the study

This improvement must last for several consecutive days to be counted as a meaningful result.

The study will compare how often this level of improvement occurs in children receiving active treatment versus placebo.

How many children will participate? The study aims to recruit about 100 children who are randomised into treatment or placebo groups. A larger group of children may be screened to ensure that only those who meet all study criteria are included.

Are there risks? All medications used in the study are already widely used in children and have well-known safety profiles. However, as with any medication, mild side effects are possible. Children with known serious allergies or previous severe reactions to the study drugs are not included.

The study includes careful monitoring, and families can contact the study team at any time if concerns arise. Participation can be stopped at any point without giving a reason, and stopping the study will not affect the child's future medical care.

Why is this study important?

This study will provide high-quality evidence on whether commonly used treatments actually help children with prolonged cough when no underlying disease is found. The results may:

Improve treatment recommendations Reduce unnecessary antibiotic and steroid use Support safer and more effective care for children

Ultimately, the findings aim to benefit children, families, and healthcare systems by promoting evidence-based treatment.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland
    • Recruiting
    • Study Site: Tampere University Hospital (TAYS), Children's and Adolescents' Hospital Outpatient Paediatrics Unit P.O. Box 2000, FI-33521 Tampere, Finland
    • Contact: Eero Lauhkonen, MD, PhD; Phone Number: +358-44-4728600; Email: eero.lauhkonen@pirha.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dry cough; Fluticasone propionate inhalation	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: Placebo inhalation; Evohaler training inhaler; puff twice daily via spacerDuration of treatment:; months
Active Comparator: Productive (Wet) Cough; Amoxicillin-clavulanic acid oral suspension	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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to earliest significant reduction or resolution of cough.	Time to earliest significant reduction or resolution of cough counted from the start of the treatment intervention.	Immediately after the intervention
Mean cough symptom diary scores before treatment intervention	Mean cough symptom diary scores: daytime Verbal Category Descriptive (day-VCD, scale 0-5), nighttime Verbal Category Descriptive (night-VCD, scale 0-5), Visual Analogue Scale (VAS, scale 0-100), in all scales increase on the scale means worse outcome.	Baseline
Mean cough symptom diary scores during intervention	Mean cough symptom diary scores obtained in specified time-points during intervention. Daytime Verbal Category Descriptive (day-VCD, scale 0-5), nighttime Verbal Category Descriptive (night-VCD, scale 0-5), Visual Analogue Scale (VAS, scale 0-100), in all scales increase on the scale means worse outcome.	7 and 14 days (productive/wet cough), and 2, 4, 6, and 8 weeks (dry cough) from baseline
Change in cough symptom scores	Change in daytime and nighttime cough symptom scores on the VCD scale (% change from baseline to follow-up). Daytime Verbal Category Descriptive (day-VCD, scale 0-5), nighttime Verbal Category Descriptive (night-VCD, scale 0-5), in all scales increase on the scale means worse outcome.	Immediately after the intervention
Change in cough severity	Change in cough severity on the VAS scale (% change from baseline to follow-up). Visual Analogue Scale (VAS, scale 0-100), increase on the scale means worse outcome.	Immediately after the intervention
Family burden caused by the child's prolonged cough	Structured questionnaire evaluating how much each domain disturbs family life, scale 1-10, increase on the scale means worse outcome, included domains: child's absence from daycare (scale 1-10, number of days during last 6 months); child's absence from free time activities/hobbies (scale 1-10, number of times during last 6 months); parent´s absence from work due to child care (scale 1-10, number of days during last 6 months); increased expenses due to child's cough (including medicine costs, absence from work, travel costs, need for child care, doctors visits) (scale 1-10, parent estimated costs during last 6 months); nighttime awakenings due to child's cough (scale 1-10); disturbance to child's everyday activities (eating, playing) due to cough (scale 1-10); parental worry due to cough (scale 1-10)	Baseline
Generic Pediatric Quality of Life	Parent-reported generic age-specific quality of life (Pediatric Quality of Life Inventory, PedsQL). Reported domains are physical, social, emotional and school functioning. Items are collected on a scale 0-4, scores transformed on scale from 0 to 100 where higher score means higher Quality of Life.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Underlying conditions	Underlying conditions associated with cough identified at the study visit (diagnoses, number, percentage)	Baseline
Asthma identified at the study visit	Asthma-suggestive symptoms and diagnostic findings; number and percentage	Baseline
Specific cause (diagnosis) of prolonged cough identified	Specific cause (diagnosis) of prolonged cough vs. non-specific cough despite initial clinical investigations (ERS 2020)	Baseline
Positive cough pointers (not necessarily diagnostic) identified	Positive cough pointers (not necessarily diagnostic) identified at screening visit vs. non-specific cough despite initial investigations (ERS 2020)	Baseline
Spontaneous resolution of cough	Spontaneous resolution of cough prior to the study visit (as reported by parents; symptom diary daytime and nighttime VCD ≤1 and VAS ≤30). Daytime Verbal Category Descriptive (day-VCD, scale 0-5), nighttime Verbal Category Descriptive (night-VCD, scale 0-5), Visual Analogue Scale (VAS, scale 0-100), in all scales increase on the scale means worse outcome.	Baseline
Emergency department visits or hospitalizations due to cough	Emergency department visits or hospitalizations prior to the study visit due to a cough-related illness, based on medical records (number, percentage category, number of events)	Baseline
Cough type	Classification of cough as wet or dry based on audio recordings (number, percentage)	Baseline
Treament non-compliance	Discontinuation of the treatment intervention due to failure of medication administration	Immediately after the intervention
Parent reported adverse events	Parent-reported adverse events related to the study medication	Immediately after the intervention
Serious adverse events	Serious adverse events related to the study medication	Immediately after the intervention
Further referral or follow-up	Participants referred to further clinical investigations or follow-up at the control visit due to persistent cough symptoms (number, percentage)	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Tampere University Hospital

Publications and helpful links

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Child; Phase III; Randomized Controlled Trial; Fluticasone Propionate; Double-Blind Method; Chronic Cough; Amoxicillin-Potassium Clavulanate Combination
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Cough
• Other Study ID Numbers: 2025-520697-19-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No