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
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: Montelukast
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by IMMUNOe International Research Centers:

Primary Outcome Measures:
  • Change in Percentage of Body Involvement [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 9 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 20
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Montelukast
Drug: 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 Comparator: 2 Drug: Placebo
Oral granules or chewable tablet, PO QD (given oral daily)

  Eligibility

Ages Eligible for Study:   1 Year to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557284

Locations
United States, Colorado
1st Allergy & Clinical Research Centers
Centennial, Colorado, United States, 80112
1st Allergy & Clinical Research Centers
Thornton, Colorado, United States, 80229
Sponsors and Collaborators
1st Allergy & Clinical Research Center
Investigators
Principal Investigator: Isaac R Melamed, MD 1st Allergy & Clinical Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Isaac Melamed, Principle Investigator, 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

Keywords provided by IMMUNOe International Research Centers:
Atopic Dermatitis (Eczema) associated with food allergies

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 28, 2015