Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Isaac Melamed, 1st Allergy & Clinical Research Center
ClinicalTrials.gov Identifier:
NCT00557284
First received: November 9, 2007
Last updated: March 31, 2015
Last verified: March 2015
Results First Received: July 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: Montelukast
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty-three subjects were screened for the trial; 20 subjects met all inclusion and exclusion criteria; 13 failed to meet all inclusion criteria.

Reporting Groups
  Description
Treatment Arm 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 Arm Placebo : Oral granules or chewable tablet, POQD

Participant Flow:   Overall Study
    Treatment Arm     Placebo Arm  
STARTED     9     11  
COMPLETED     9     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Treatment Arm 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 Arm Placebo : Oral granules or chewable tablet, POQD
Total Total of all reporting groups

Baseline Measures
    Treatment Arm     Placebo Arm     Total  
Number of Participants  
[units: participants]
  9     11     20  
Age  
[units: participants]
     
<=18 years     9     11     20  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  5.5  (2.3)     5.6  (1.7)     5.5  (2.0)  
Gender  
[units: participants]
     
Female     5     5     10  
Male     4     6     10  
Region of Enrollment  
[units: participants]
     
United States     9     11     20  
Percentage of Body Involvement [1]
[units: percentage]
Mean (Standard Deviation)
  21.67  (8.9)     20.05  (8.1)     20.86  (8.5)  
Investigator Global Assessment (IGA) [2]
[units: Scores on a scale]
Mean (Standard Deviation)
  2.11  (0.33)     2.30  (0.48)     2.20  (0.40)  
PADC (caregivers assessment of disease control) [3]
[units: Scores on a scale]
Mean (Standard Deviation)
  1.78  (0.67)     1.80  (0.92)     1.79  (0.80)  
Pruritus score [4]
[units: units on a scale]
Mean (Standard Deviation)
  1.60  (0.79)     1.17  (0.72)     1.36  (0.30)  
IL-13 [5]
[units: pg/ml]
Mean (Standard Deviation)
  33.67  (30.20)     34.70  (37.0)     34.18  (33.60)  
TNF alpha [6]
[units: pg/ml]
Mean (Standard Deviation)
  1.87  (0.87)     5.70  (11.03)     3.78  (5.95)  
NGF [7]
[units: pg/ml]
Mean (Standard Deviation)
  99.78  (167.38)     108.70  (192.35)     104.24  (179.86)  
Urine LTE4 [8]
[units: pg/ml]
Mean (Standard Deviation)
  52.90  (40.20)     66.65  (62.90)     59.77  (51.55)  
IgE [9]
[units: kU/L]
Mean (Standard Deviation)
  432.20  (887.90)     392.40  (441.00)     412.30  (664.45)  
GSRS [10]
[units: Scores on a scale]
Mean (Standard Deviation)
  4.67  (2.5)     5.0  (2.4)     4.83  (2.45)  
[1] Percentage of body surface as calculated by investigator. Measurement is mean for all subjects in each arm.
[2] 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.
[3] 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.
[4] 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.
[5] Serum interleukin 13 levels. Measurement is the mean for all subjects in each arm.
[6] Serum Tumor Necrosis Factor levels. Measurement is the mean for all subjects in each arm.
[7] Serum Nerve Growth Factor levels. Measurement is the mean for all subjects in each arm.
[8] Urine Cysteinyl leukotriene 4 levels. Measurement is the mean for all subjects in each arm.
[9] Serum Immunoglobulin E levels. Measurement is the mean for all subjects in each arm.
[10] 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.



  Outcome Measures
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1.  Primary:   Change in Percentage of Body Involvement   [ Time Frame: Baseline and 9 weeks ]

2.  Primary:   Mean Change in Investigator Global Assessment (IGA)   [ Time Frame: Baseline and 9 weeks ]

3.  Primary:   Mean Change in PADC (Caregivers Perception of Disease Control)   [ Time Frame: Baseline and 9 weeks ]

4.  Primary:   Mean Change in Pruritus   [ Time Frame: Baseline and 9 weeks ]

5.  Primary:   Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream   [ Time Frame: Baseline and 9 weeks ]

6.  Secondary:   Mean Change in Serum and Urinary Inflammatory Marker Levels   [ Time Frame: Baseline and 9 weeks ]

7.  Secondary:   Mean Change in Serum IgE Levels   [ Time Frame: Baseline and 9 weeks ]

8.  Secondary:   Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS   [ Time Frame: Baseline and 9 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Dr. Isaac Melamed, principle investigator
Organization: IMMUNOe International Research Centers
phone: 303-773-9000
e-mail: melamedi@immunoe.com


No publications provided


Responsible Party: Isaac Melamed, 1st Allergy & Clinical Research Center
ClinicalTrials.gov Identifier: NCT00557284     History of Changes
Other Study ID Numbers: 32032
Study First Received: November 9, 2007
Results First Received: July 30, 2013
Last Updated: March 31, 2015
Health Authority: United States: Institutional Review Board