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Finnish Children´s Protracted Cough

ConditionChronic Cough
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-6
SponsorTampere University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

  • Placebo inhalation

    Drug

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

  • 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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Dry coughActive comparator 2 interventions
Group B: Productive (Wet) CoughActive comparator 2 interventions

Trial outcomes

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

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Immediately after the intervention

Other outcomes

1

Underlying conditions

Underlying conditions associated with cough identified at the study visit (diagnoses, number, percentage)

Time frame
Baseline
2

Asthma identified at the study visit

Asthma-suggestive symptoms and diagnostic findings; number and percentage

Time frame
Baseline
3

Specific cause (diagnosis) of prolonged cough identified

Specific cause (diagnosis) of prolonged cough vs. non-specific cough despite initial clinical investigations (ERS 2020)

Time frame
Baseline
4

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)

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tampere University Hospital

Lead sponsor

Source ClinicalTrials.gov
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