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Chronic CoughPhase 3FINNCHICONCT07582549

Finnish Children´s Protracted Cough

A Phase 3 study testing Fluticasone propionate inhalation and Amoxicillin-clavulanic acid oral suspension in people with Chronic Cough, run by Tampere University Hospital at 1 site in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 6 years
Conditions the study is for
Chronic Cough
What is being tested?
Fluticasone propionate inhalation and Amoxicillin-clavulanic acid oral suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteFinland
Study dates
22 Dec 2025to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Finland1 site, 1 recruiting
  • Study Site: Tampere University Hospital (TAYS), Children's and Adolescents' Hospital Outpatient Paediatrics Unit P.O. Box 2000, FI-33521 Tampere, Finland

    Tampere

    Eero Lauhkonen, MD, PhD, +358-44-4728600, eero.lauhkonen@pirha.fi

    Recruiting

Other trials in Finland

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Chronic Cough
Being tested
Fluticasone propionate inhalation, Amoxicillin-clavulanic acid oral suspension, Placebo inhalation, Placebo oral suspension
Keywords
Chronic Cough, Child, Fluticasone Propionate, Amoxicillin-Potassium Clavulanate Combination, Randomized Controlled Trial, Double-Blind Method, Phase III
Medical subject headings
Chronic Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluticasone propionate inhalationDrug

    Fluticasone propionate 125 micrograms (Trade name: Flixotide Evohaler)

    Administration (all ages):

    125 micrograms (1 puff) twice daily via spacer

    Duration of treatment:

    2 months

  • Amoxicillin-clavulanic acid oral suspensionDrug

    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

  • Placebo inhalationDrug

    Evohaler training inhaler

    1. puff twice daily via spacer Duration of treatment:
    2. months
  • Placebo oral suspensionDrug

    Syrspend oral suspension base thickened with microcrystalline cellulose, without active pharmaceutical ingredient, administered with the same weight-adjusted regimen.

    Duration of treatment:

    2 weeks

Study groups in NCT07582549
Study groupRoleWhat they receive
Dry coughActive comparatorFluticasone propionate inhalation
Receives: Drug: Fluticasone propionate inhalation; Drug: Placebo inhalation
Productive (Wet) CoughActive comparatorAmoxicillin-clavulanic acid oral suspension
Receives: Drug: Amoxicillin-clavulanic acid oral suspension; Drug: Placebo oral suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (7)
  1. 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.

    Measured: Immediately after the intervention

  2. 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.

    Measured: Baseline

  3. 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.

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

  4. 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.

    Measured: Immediately after the intervention

  5. 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.

    Measured: Immediately after the intervention

  6. 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:

    1. child's absence from daycare (scale 1-10, number of days during last 6 months)
    2. child's absence from free time activities/hobbies (scale 1-10, number of times during last 6 months)
    3. parent´s absence from work due to child care (scale 1-10, number of days during last 6 months)
    4. 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)
    5. nighttime awakenings due to child's cough (scale 1-10)
    6. disturbance to child's everyday activities (eating, playing) due to cough (scale 1-10)
    7. parental worry due to cough (scale 1-10)

    Measured: Baseline

  7. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start22 Dec 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, double-blind, placebo-controlled parallel-group clinical trial, stratified by cough type (dry vs wet)
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07582549
Sponsor's protocol ID
2025-520697-19-00
Other IDs
2025
Acronym
FINNCHICO
Status last verified
Apr 2026
First submitted
28 Apr 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone propionate inhalation and Amoxicillin-clavulanic acid oral suspension in people with Chronic Cough, run by Tampere University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Significant cough resolution (time frame: Immediately after the intervention (2 months or 2 weeks from baseline depending on treatment arm)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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