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Trial record 18 of 154 for:    Dermatitis, Atopic, 8

The Effectiveness of Montelukast on Atopic Dermatitis in Koreans

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ClinicalTrials.gov Identifier: NCT00903357
Recruitment Status : Completed
First Posted : May 18, 2009
Results First Posted : September 13, 2012
Last Update Posted : December 14, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Pyun BokYang, Soonchunhyang University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: Montelukast first, then placebo
Drug: Placebo first, then Montelukast
Enrollment 54
Recruitment Details 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).
Pre-assignment Details 54 participants recruited.
Arm/Group Title Montelukast First, Then Placebo Placebo First, Then Montelukast
Hide Arm/Group Description 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(chewable ascorbic acid) once daily in first intervention period and Montelukast(4mg or 5mg) once daily in second intervention period (after washout period).
Period Title: First Intervention
Started 27 27
Completed 22 23
Not Completed 5 4
Reason Not Completed
Withdrawal by Subject             5             3
Flu             0             1
Period Title: Wash Out Period of 2 Weeks
Started 22 23
Completed 22 22
Not Completed 0 1
Reason Not Completed
Flu             0             1
Period Title: Second Intervention
Started 22 22
Completed 21 22
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive Montelukast first and placebo first.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 54 participants
46.0  (16.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
27
  50.0%
Male
27
  50.0%
Severity of atopic dermatitis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
moderate 26
severe 28
[1]
Measure Description: Severity of atopic dermatitis using SCORAD index. Moderate : 15~40, Severe : >40.
1.Primary Outcome
Title Changes in SCORAD Index
Hide Description 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)
Time Frame 18 weeks after patient recruitment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Montelukast Sodium Placebo Drug
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.0  (11.2) -5.7  (11.3)
2.Primary Outcome
Title Changes in Urinary LTE4
Hide Description 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.
Time Frame 18 weeks after patient recruitment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Montelukast Sodium Placebo Drug
Hide Arm/Group Description:
Changes of Urine LTE4 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 urinary LTE4 before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
Changes of Urine LTE4 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 urinary LTE4 before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
Overall Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: Urinary LTE4 (pg/ml)
-65.9  (556.2) 87.7  (618.3)
3.Primary Outcome
Title Changes in Urinary EDN
Hide Description 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.
Time Frame 18 weeks after participants recruitment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Montelukast Sodium Placebo Drug
Hide Arm/Group Description:
Changes of Urine EDN 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 urinary EDN before and after taking Montelukast sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
Changes of Urine EDN 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 urinary EDN before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
Overall Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: Urine EDN (ng/ml)
37.0  (1008.6) -195.8  (916.7)
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Montelukast Sodium Placebo Drug
Hide Arm/Group Description Montelukast sodium(4mg or 5mg) administered once daily in either first intervention period or second intervention period. Placebo drug administered once daily in either first intervention period or second intervention period.
All-Cause Mortality
Montelukast Sodium Placebo Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Montelukast Sodium Placebo Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Montelukast Sodium Placebo Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bok Yang Pyun, M.D.
Organization: Department of Pediatrics, Soonchunhyang University Hospital
Phone: +82-2-709-9339
EMail: bypyun@hanmail.net
Layout table for additonal information
Responsible Party: Pyun BokYang, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT00903357     History of Changes
Other Study ID Numbers: schallergy
First Submitted: May 14, 2009
First Posted: May 18, 2009
Results First Submitted: July 8, 2011
Results First Posted: September 13, 2012
Last Update Posted: December 14, 2015