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Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

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ClinicalTrials.gov Identifier: NCT00557284
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : December 9, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Isaac Melamed, 1st Allergy & Clinical Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: Montelukast
Drug: Placebo
Enrollment 20
Recruitment Details The study was conducted at 2 outpatient clinics in the Denver, Colorado, metropolitan area between February 2008 and March 2009. Individual subject participation lasted for approximately 9 weeks.
Pre-assignment Details Thirty-three subjects were screened for the trial; 20 subjects met all inclusion and exclusion criteria; 13 failed to meet all inclusion criteria.
Arm/Group Title Treatment Arm Placebo Arm
Hide Arm/Group Description Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age Placebo : Oral granules or chewable tablet, POQD
Period Title: Overall Study
Started 9 11
Completed 9 11
Not Completed 0 0
Arm/Group Title Treatment Arm Placebo Arm Total
Hide Arm/Group Description Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age Placebo : Oral granules or chewable tablet, POQD Total of all reporting groups
Overall Number of Baseline Participants 9 11 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
<=18 years
9
 100.0%
11
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 11 participants 20 participants
5.5  (2.3) 5.6  (1.7) 5.5  (2.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
Female
5
  55.6%
5
  45.5%
10
  50.0%
Male
4
  44.4%
6
  54.5%
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 11 participants 20 participants
9 11 20
Percentage of Body Involvement   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 9 participants 11 participants 20 participants
21.67  (8.9) 20.05  (8.1) 20.86  (8.5)
[1]
Measure Description: Percentage of body surface as calculated by investigator. Measurement is mean for all subjects in each arm.
Investigator Global Assessment (IGA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 9 participants 11 participants 20 participants
2.11  (0.33) 2.30  (0.48) 2.20  (0.40)
[1]
Measure Description: The IGA is a six-point measure of disease severity are evaluated by the study doctor based on the overall assessment of skin lesions: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5= very severe. Measurement is the mean for all subjects in each arm.
PADC (caregivers assessment of disease control)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 9 participants 11 participants 20 participants
1.78  (0.67) 1.80  (0.92) 1.79  (0.80)
[1]
Measure Description: Caregiver’s evaluation of disease control over the previous 7 days and will consist of a four-point scale ranging from complete control (0) to uncontrolled disease (3). Measurement is the mean for all subjects in each arm.
Pruritus score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants 11 participants 20 participants
1.60  (0.79) 1.17  (0.72) 1.36  (0.30)
[1]
Measure Description: Pruritus assessments (“itch”) will be recorded for the previous 24 hours using a 4 point-scale, ranging from none (0) to severe (3). Measurement is mean of all subjects in each arm.
IL-13   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/ml
Number Analyzed 9 participants 11 participants 20 participants
33.67  (30.20) 34.70  (37.0) 34.18  (33.60)
[1]
Measure Description: Serum interleukin 13 levels. Measurement is the mean for all subjects in each arm.
TNF alpha   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/ml
Number Analyzed 9 participants 11 participants 20 participants
1.87  (0.87) 5.70  (11.03) 3.78  (5.95)
[1]
Measure Description: Serum Tumor Necrosis Factor levels. Measurement is the mean for all subjects in each arm.
NGF   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/ml
Number Analyzed 9 participants 11 participants 20 participants
99.78  (167.38) 108.70  (192.35) 104.24  (179.86)
[1]
Measure Description: Serum Nerve Growth Factor levels. Measurement is the mean for all subjects in each arm.
Urine LTE4   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/ml
Number Analyzed 9 participants 11 participants 20 participants
52.90  (40.20) 66.65  (62.90) 59.77  (51.55)
[1]
Measure Description: Urine Cysteinyl leukotriene 4 levels. Measurement is the mean for all subjects in each arm.
IgE   [1] 
Mean (Standard Deviation)
Unit of measure:  kU/L
Number Analyzed 9 participants 11 participants 20 participants
432.20  (887.90) 392.40  (441.00) 412.30  (664.45)
[1]
Measure Description: Serum Immunoglobulin E levels. Measurement is the mean for all subjects in each arm.
GSRS   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 9 participants 11 participants 20 participants
4.67  (2.5) 5.0  (2.4) 4.83  (2.45)
[1]
Measure Description: GI symptoms will be recorded weekly on *GSRS validated scale adjusted for pediatrics (*Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome and Peptic Ulcer Disease). This scale measures 7 different GI symptoms (1. abdominal pain; 2. nausea and vomiting; 3. abdominal dissention; 4. decreased passage of stools; 5. increased passage of stools; 6. loose stools; 7. hard stools) with severity ranges from 0 - 3 (maximum total of 21 - most severe). Measurement is the mean for all subjects in each arm.
1.Primary Outcome
Title Change in Percentage of Body Involvement
Hide Description Change in percentage of body involvement from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm for AD as measured by study investigator
Time Frame Baseline and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Placebo Arm
Hide Arm/Group Description:
Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
Placebo : Oral granules or chewable tablet, POQD
Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: Change of percentage in body involvement
-2.0  (12.2) 0.15  (20.2)
2.Primary Outcome
Title Mean Change in Investigator Global Assessment (IGA)
Hide Description The mean change in IGA from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. The IGA is a six-point measure of disease severity and is evaluated by the investigator based on the overall assessment of skin lesions: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5= very severe.
Time Frame Baseline and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Placebo Arm
Hide Arm/Group Description:
Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
Placebo : Oral granules or chewable tablet, POQD
Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-.11  (1.7) -.70  (.95)
3.Primary Outcome
Title Mean Change in PADC (Caregivers Perception of Disease Control)
Hide Description Mean change in PADC from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Caregiver’s evaluation of disease control over the previous 7 days and will consist of a four-point scale ranging from complete control (0) to uncontrolled disease (3)
Time Frame Baseline and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Placebo Arm
Hide Arm/Group Description:
Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
Placebo : Oral granules or chewable tablet, POQD
Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-.78  (1.1) -0.10  (1.4)
4.Primary Outcome
Title Mean Change in Pruritus
Hide Description Mean change in pruritus scores from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Pruritus assessments (“itch”) will be recorded for the previous 24 hours using a 4 point-scale, ranging from none (0) to severe (3). Scores are cumulative per week.
Time Frame Baseline and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Placebo Arm
Hide Arm/Group Description:
Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
Placebo : Oral granules or chewable tablet, POQD
Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.82  (0.78) 0.32  (0.45)
5.Primary Outcome
Title Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream
Hide Description Average of weekly use of cetirizine and/or 10% hydrocortisone cream will be compared for all subjects in each arm from week 1 to week 9. Flare-up is defined as a worsening of the disease that is unacceptable to the participants and leads to second line topical steroid use and/or liquid anti-histamine use. Measurement is noted as 1 for daily use (does not correspond to multiple uses per day).
Time Frame Baseline and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Placebo Arm
Hide Arm/Group Description:
Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
Placebo : Oral granules or chewable tablet, POQD
Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: days/week
Cetirizine use -0.56  (0.88) 0.91  (2.1)
10% Hydrocortisone cream use 0.78  (2.7) 2.0  (3.3)
6.Secondary Outcome
Title Mean Change in Serum and Urinary Inflammatory Marker Levels
Hide Description Mean change in levels from baseline to study visit 4 (week 1 compared to week 9)for interleukin 3 (IL3), tumor necrosis factor alpha (TNF alpha), nerve growth factor (NGF), and urinary leukotriene E4 (LTE4)
Time Frame Baseline and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Placebo Arm
Hide Arm/Group Description:
Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
Placebo : Oral granules or chewable tablet, POQD
Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: pg/ml
IL3 -9.0  (43.9) -7.9  (53.7)
TNF alpha 2.3  (5.5) -16.4  (13.6)
NGF 30.9  (306.7) -58.8  (198.3)
Urine LTE4 -2.1  (46.2) -20.42  (65.0)
7.Secondary Outcome
Title Mean Change in Serum IgE Levels
Hide Description Mean change in serum levels of IgE from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm.
Time Frame Baseline and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Placebo Arm
Hide Arm/Group Description:
Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
Placebo : Oral granules or chewable tablet, POQD
Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: kU/L
100.5  (355.6) 216.1  (505.9)
8.Secondary Outcome
Title Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS
Hide Description The mean change from baseline to study visit 4 (week 1 compared to week 9) in GRGS scores (GI symptoms will be recorded on *GSRS validated scale adjusted for pediatrics (*Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome and Peptic Ulcer Disease) for all subjects in each arm.This scale measures 7 different GI symptoms (1. abdominal pain; 2. nausea and vomiting; 3. abdominal dissention; 4. decreased passage of stools; 5. increased passage of stools; 6. loose stools; 7. hard stools) with severity ranges from 0 - 3 for each point (0 being no complaint and 3 being most severe for a maximum total of 21).
Time Frame Baseline and 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Placebo Arm
Hide Arm/Group Description:
Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
Placebo : Oral granules or chewable tablet, POQD
Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.03  (3.1) -4.1  (3.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm Placebo Arm
Hide Arm/Group Description Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age Placebo : Oral granules or chewable tablet, POQD
All-Cause Mortality
Treatment Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Isaac Melamed, principle investigator
Organization: IMMUNOe International Research Centers
Phone: 303-773-9000
EMail: melamedi@immunoe.com
Layout table for additonal information
Responsible Party: Isaac Melamed, 1st Allergy & Clinical Research Center
ClinicalTrials.gov Identifier: NCT00557284     History of Changes
Other Study ID Numbers: 32032
First Submitted: November 9, 2007
First Posted: November 12, 2007
Results First Submitted: July 30, 2013
Results First Posted: December 9, 2014
Last Update Posted: April 21, 2015