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RCT ICS/FeNO for Cough in Children

Randomised Placebo Controlled Trial of Inhaled Corticosteroids for Treatment of Acute Cough in Children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003182
Enrollment
Unknown
Registered
2013-04-26
Start date
2013-06-01
Completion date
Unknown
Last updated
2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cough in Children

Interventions

Two groups:Fluticasone propionate inhaler 250mcg twice per day versus placebo inhaler

Sponsors

Department of Paediatrics, CUHK
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1) Male or female child aged >=18 months and <16 years; 2) Presenting with an acute cough (acute cough defined as cough duration of less than 2 weeks); 3) Provision of written informed consent from parent/legal guardian.

Exclusion criteria

Exclusion criteria: 1) Children who have taken oral or inhaled corticosteroids in the week prior to enrolment; 2) Children who are unable to tolerate inhaled corticosteroids or spacer with or without a mask; 3) Children who have a physician-confirmed underlying chronic respiratory illness; 4) Radiological diagnosis of pneumonia and/or admission to hospital for respiratory illness; 5) Children who are immunocompromised; 6) Children who have cerebral palsy or severe neuro-developmental abnormality.

Design outcomes

Secondary

MeasureTime frame
1) Days to resolution of cough;2) Quality of Life scores – PCQOL, Paeds QOL and VAS (To be completed weekly for 4 weeks);3) Scores on the validated cough diary cards (To be completed daily over 4 weeks);4) Incidence of adverse events - unscheduled doctor visits, number of medication doses missed, number;5) Presence of viral infection detected at baseline, day 14 and day 28;

Primary

MeasureTime frame
Good response to ICS treatment defined as a change of 1 in cough VCD score from baseline (average);

Countries

China

Contacts

Public ContactAlbert Martin LI

The Chinese University of Hong Kong

albertmli@cuhk.edu.hk+852 2632 2982

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026