search
Back to results

Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Montelukast
Placebo
Sponsored by
1st Allergy & Clinical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis (Eczema) associated with food allergies

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Mild to moderate atopic dermatitis involving greater than or equal to 5% of body surface
  2. Total severity score of 2 or greater for any 3 of the 4 signs and symptoms calculated by study doctor (erythema, papulation, or lichenification)
  3. Positive skin or (radioallergosorbent) RAST tests by ImmunoCap to food or environmental allergens
  4. GI symptoms total score of 2 by caregiver on GSRS scale revised for pediatrics

Exclusion Criteria:

  1. Participants with intolerance or allergy to montelukast.
  2. History of anaphylaxis requiring hospitalization.
  3. No underlying renal or liver disease.
  4. Participants with a diagnosis of severe asthma.
  5. Participants diagnosed with primary immune deficiency.
  6. Participants using sublingual immunotherapy.
  7. Immunotherapy must be a maintenance dose for a minimum of 30 days.
  8. If on gastrointestinal medication, 30 day stable dose before visit 1 and maintained throughout the study.

Sites / Locations

  • 1st Allergy & Clinical Research Centers
  • 1st Allergy & Clinical Research Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Montelukast

Outcomes

Primary Outcome Measures

Change in Percentage of Body Involvement
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
Mean Change in Investigator Global Assessment (IGA)
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.
Mean Change in PADC (Caregivers Perception of Disease Control)
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)
Mean Change in Pruritus
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.
Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream
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).

Secondary Outcome Measures

Mean Change in Serum and Urinary Inflammatory Marker Levels
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)
Mean Change in Serum IgE Levels
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.
Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS
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).

Full Information

First Posted
November 9, 2007
Last Updated
March 31, 2015
Sponsor
1st Allergy & Clinical Research Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00557284
Brief Title
Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Montelukast (Singulair) in Participants Ages 1 - 8 Years Diagnosed With Atopic Dermatitis Induced by Food Allergens
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
1st Allergy & Clinical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
AD is a disease found in children; the focus of the study is the mechanisms associated in children with AD induced by food allergies. This study will be a randomized, double-blind, placebo-controlled, parallel group trial conducted in participants diagnosed with atopic dermatitis and food allergies. The study duration for participants will be approximately 9 weeks. A total of 20 participants will be recruited for the entire study. Each arm will consist of 10 participants.The study will enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated with food allergens, previously documented by skin or RAST test, before enrollment. Atopic dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis (Eczema) associated with food allergies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Montelukast
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral granules or chewable tablet, PO QD (given oral daily)
Primary Outcome Measure Information:
Title
Change in Percentage of Body Involvement
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
Title
Mean Change in Investigator Global Assessment (IGA)
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
Title
Mean Change in PADC (Caregivers Perception of Disease Control)
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
Title
Mean Change in Pruritus
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
Title
Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream
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
Secondary Outcome Measure Information:
Title
Mean Change in Serum and Urinary Inflammatory Marker Levels
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
Title
Mean Change in Serum IgE Levels
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
Title
Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild to moderate atopic dermatitis involving greater than or equal to 5% of body surface Total severity score of 2 or greater for any 3 of the 4 signs and symptoms calculated by study doctor (erythema, papulation, or lichenification) Positive skin or (radioallergosorbent) RAST tests by ImmunoCap to food or environmental allergens GI symptoms total score of 2 by caregiver on GSRS scale revised for pediatrics Exclusion Criteria: Participants with intolerance or allergy to montelukast. History of anaphylaxis requiring hospitalization. No underlying renal or liver disease. Participants with a diagnosis of severe asthma. Participants diagnosed with primary immune deficiency. Participants using sublingual immunotherapy. Immunotherapy must be a maintenance dose for a minimum of 30 days. If on gastrointestinal medication, 30 day stable dose before visit 1 and maintained throughout the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaac R Melamed, MD
Organizational Affiliation
1st Allergy & Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Allergy & Clinical Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
1st Allergy & Clinical Research Centers
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.immunoeresearch.com
Description
Research website

Learn more about this trial

Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

We'll reach out to this number within 24 hrs