Trial Outcomes & Findings for The Effectiveness of Montelukast on Atopic Dermatitis in Koreans (NCT NCT00903357)

Last Updated: 2015-12-14

Results Overview

Changes of SCORAD(SCORing Atopic Dermatitis) index after taking Montelukast or placebo drug. SCORAD calculation: Extent(%)/5 + 7\*Intensity/2 + subjective symptoms (minimum score 0, maximum score 103) (SCORAD index \>40: severe, 15-40:moderate, \<15: mild)

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

18 weeks after patient recruitment

Results posted on

2015-12-14

Participant Flow

Childrens(2\~6 years old) with moderate to severe atopic dermatitis recruited from the Pediatric Allergy and respiratory Center of the SoonChunHyang University Hospital (Seoul, Korea).

54 participants recruited.

Participant milestones

Participant milestones
Measure	Montelukast First, Then Placebo Montelukast(4mg or 5mg) once daily in first intervention period and placebo(chewable ascorbic acid) once daily in second intervention period (after washout period).	Placebo First, Then Montelukast Placebo(chewable ascorbic acid) once daily in first intervention period and Montelukast(4mg or 5mg) once daily in second intervention period (after washout period).
First Intervention STARTED	27	27
First Intervention COMPLETED	22	23
First Intervention NOT COMPLETED	5	4
Wash Out Period of 2 Weeks STARTED	22	23
Wash Out Period of 2 Weeks COMPLETED	22	22
Wash Out Period of 2 Weeks NOT COMPLETED	0	1
Second Intervention STARTED	22	22
Second Intervention COMPLETED	21	22
Second Intervention NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Montelukast First, Then Placebo Montelukast(4mg or 5mg) once daily in first intervention period and placebo(chewable ascorbic acid) once daily in second intervention period (after washout period).	Placebo First, Then Montelukast Placebo(chewable ascorbic acid) once daily in first intervention period and Montelukast(4mg or 5mg) once daily in second intervention period (after washout period).
First Intervention Withdrawal by Subject	5	3
First Intervention Flu	0	1
Wash Out Period of 2 Weeks Flu	0	1
Second Intervention Lost to Follow-up	1	0

Baseline Characteristics

The Effectiveness of Montelukast on Atopic Dermatitis in Koreans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=54 Participants Includes groups randomized to receive Montelukast first and placebo first.
Age, Continuous	46.0 months STANDARD_DEVIATION 16.1 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Severity of atopic dermatitis moderate	26 participants n=5 Participants
Severity of atopic dermatitis severe	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 weeks after patient recruitment

Outcome measures

Outcome measures
Measure	Montelukast Sodium n=43 Participants Changes of SCORAD index after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)	Placebo Drug n=43 Participants Changes of SCORAD index after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
Changes in SCORAD Index	-3.0 units on a scale Standard Deviation 11.2	-5.7 units on a scale Standard Deviation 11.3

PRIMARY outcome

Timeframe: 18 weeks after patient recruitment

Changes of Urinary LTE4(Leukotrien E4) after taking Montelukast or placebo drug. Urinary LTE4 levels were measured using an enzyme-linked immunoassay (ELISA) (Cayman Chemical, Michigan, USA) and the intra-assay and inter-assay variations were 7.4 ± 2.1 and 12.4 ± 7.8, respectively. Minimum value : 0 Maximum vlaue: 1000 pg/ml.

Outcome measures

Outcome measures
Measure	Montelukast Sodium n=43 Participants Changes of SCORAD index after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)	Placebo Drug n=43 Participants Changes of SCORAD index after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
Changes in Urinary LTE4	-65.9 Urinary LTE4 (pg/ml) Standard Deviation 556.2	87.7 Urinary LTE4 (pg/ml) Standard Deviation 618.3

PRIMARY outcome

Timeframe: 18 weeks after participants recruitment

Changes of Urinary EDN(Eosinophil Derived Neurotoxin) after taking Montelukast or placebo drug. Urinary EDN levels were measured using an ELISA (MBL, Woburn, MA, USA) and the intra-assay and inter-assay variations were 3.0 ± 0.5 and 7.7 ± 1.5, respectively. Minimum value: 0, Maximum value: 2040 ng/ml.

Outcome measures

Outcome measures
Measure	Montelukast Sodium n=43 Participants Changes of SCORAD index after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)	Placebo Drug n=43 Participants Changes of SCORAD index after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
Changes in Urinary EDN	37.0 Urine EDN (ng/ml) Standard Deviation 1008.6	-195.8 Urine EDN (ng/ml) Standard Deviation 916.7

Adverse Events

Montelukast Sodium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bok Yang Pyun, M.D.

Department of Pediatrics, Soonchunhyang University Hospital

Phone: +82-2-709-9339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60