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Trial History Detail on 2017-05-09

CUHK_CCT00366

2013-04-26

Prospective

N/A

Department of Paediatrics, CUHK

Department of Paediatrics, CUHK

N/A

Not Applicable

Chun Ting AU

Department of Paediatrics, 6/F, Clinical Sciences Buidling, Prince of Wales Hospital, Shatin, NT, Hong Kong

2632 2917

junau@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Albert Martin LI

Department of Paediatrics, 6/F, Clinical Sciences Buidling, Prince of Wales Hospital, Shatin, NT, Hong Kong

2632 2982

albertmli@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

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

RCT ICS/FeNO for Cough in Children

吸入式類固醇用於治療兒童急性咳嗽的隨機安慰劑對照臨床研究

N/A

Hong Kong SAR

Yes

2012-07-03

Joint CUHK-NTEC Clinical Research Ethics Committee

2012.224-T

Cough

Drug

Fluticasone propionate inhaler 250mcg twice per day

Inhaled 250mcg

250mcg twice daily

14 days

Twice daily

Placebo inhaler

N/A

N/A

N/A

N/A

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

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

18 months

16 years

Both Male and Female

Interventional

Randomized

Randomised with sealed envelope

Placebo

Double-blind

Parallel

4

2013-06-01

40

Recruiting

Good response to ICS treatment defined as a change of 1 in cough VCD score from baseline (average score from days 1,2,3) to completion of study medication (average score from days 13,14,15)

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 of days childcare/school/work missed by child/parent. (Data collected weekly for 4 weeks)
5) Presence of viral infection detected at baseline, day 14 and day 28.

No

2019-09-06

ChiCTR-TRC-13003182

2013-04-26

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