Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00366

2 Trial Registration Date

2013-04-26

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Department of Paediatrics, CUHK

5 Primary Sponsor

Department of Paediatrics, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Chun Ting AU

ii Address

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

iii Phone

2632 2917

iv Email

junau@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Albert Martin LI

ii Address

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

iii Phone

2632 2982

iv Email

albertmli@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

RCT ICS/FeNO for Cough in Children

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

N/A

12 Countries of Recruitment

Hong Kong SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-07-03

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2012.224-T

14 Medical Condition Being Studied

Cough

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Fluticasone propionate inhaler 250mcg twice per day

iii Dosage form of the intervention

Inhaled 250mcg

iv Dosage of the intervention

250mcg twice daily

v Duration of the intervention

14 days

vi Frequency of the intervention

Twice daily

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo inhaler

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i 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

ii 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

iii Age Minimum

18 months

iv Age Maximum

16 years

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomised with sealed envelope

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-06-01

21 Target Sample Size

40

22 Recruitment Status

Recruiting

23 Primary Outcome

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)

24 Secondary Outcome

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.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-09-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13003182

28 Date of Registration in Primary Registry

2013-04-26

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Trial History Detail on 2017-05-09