Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00113

2 Trial Registration Date

2006-08-31

i Registration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

MSD

5 Primary Sponsor

Prof. Albert Martin Li

6 Secondary Sponsor

Dr. Victor Abdullah

Function

Please specify

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

i Name

Tracy Tsen

ii Address

iii Phone

26322861, 26360020, tracy-tsen@cuhk.edu.hk

iv Email

Tel., fax, email

v Affiliation

vi Country

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

i Name

Prof. A.M Li

ii Address

iii Phone

26322982, albertmli@cuhk.edu.hk

iv Email

Tel., e-mail

v Affiliation

vi Country

9 Official Scientific Title of the Study

Use of Leukotriene Receptor Antagonist in the Treatment of Allergic Rhinitis

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2006-05-18

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

asthma, allergic rhinitis

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Montelukast

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

26 weeks per subject

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

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

Include: Patient from 6-18 yrs old with asthma and allergic rhinitis Exclude: Subject with congenital nasal anomalies or had received systemically administered corticosteroids within 1 month of enrollment.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

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

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2006-10-01

21 Target Sample Size

46

22 Recruitment Status

Complete

23 Primary Outcome

The primary outcome measures include nasal cytokine levels, nasal airflow and daily rhinitis scores.

24 Secondary Outcome

Secondary outcomes measures include symptom-free days, blood eosinophil counts and spirometric parameters.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-26

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2007-09-04