Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00387

2 Trial Registration Date

2014-01-14

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.600-T

4 Source(s) of Funding

Department of Paediatrics

5 Primary Sponsor

Department of Paediatrics, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Chun Ting Au

ii Address

Department of Pediatrics, 6th Floor, Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

26322982

iv Email

junau@cuhk.edu.hk

v Affiliation

Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong

vi Country

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

i Name

Albert Martin Li

ii Address

Department of Pediatrics, 6th Floor, Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

26322917

iv Email

albertmli@cuhk.edu.hk

v Affiliation

Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A randomized study of intranasal corticosteroid for childhood primary snoring – endothelial function perspective

10 Public Title

Impact of intranasal corticosteroid on endothelial function of children with primary snoring

i Public Title in Chinese 研究名稱

類固醇噴鼻治療對原發性鼻鼾症兒童的血管內皮細胞功能之影響

11 Short Title (Optional)

intranasal corticosteroid on endothelial for endothelial function of children with primary snoring

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-12-13

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

primary snoring

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

budesonide 32mcg one spray per nostril once daily

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

4 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

N/A, watchful waiting as controls

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(i) Hong Kong Chinese children and adolescents aged between 8-16 years.
(ii) Normal sleep study as documented on PSG (OAHI <1).
(iii) Non-smoker.
(iv) Written informed consent obtained from parents.

ii Exclusion Criteria

(i) Obesity, defined as having a body mass index (BMI) ≥95th percentile (corresponding to a z score of 1.645) of the local reference.[20]
(ii) Known medical conditions that could affect airway, BP control and endothelial function, for example cranio-facial, neuromuscular diseases and congenital heart disease.
(iii) Receiving medications that could alter BP control and endothelial function.
(iv) Upper respiratory tract or other infection within the past 4 weeks from recruitment.

iii Age Minimum

8

iv Age Maximum

16

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-04-01

21 Target Sample Size

104

22 Recruitment Status

Recruiting

23 Primary Outcome

flow-mediated dilatation of brachial artery

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-08-17

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004138

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-07-16