Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Isaac Melamed, M.D., 1st Allergy & Clinical Research Center
ClinicalTrials.gov Identifier:
NCT00557284
First received: November 9, 2007
Last updated: January 25, 2012
Last verified: January 2012
  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 1st Allergy & Clinical Research Center:

Primary Outcome Measures:
  • The change in validated skin assessment scores (EASI) in treating symptoms of atopic dermatitis associated with food allergens [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in serum and urinary inflammatory marker levels [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • The change in GSRS validated scale for treating gastrointestinal symptoms induced by food allergens [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

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 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, POQD

  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 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
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Isaac R Melamed, MD 1st Allergy & Clinical Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Isaac Melamed, M.D., 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
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 1st Allergy & Clinical Research Center:
Atopic Dermatitis (Eczema) associated with food allergies

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

ClinicalTrials.gov processed this record on July 26, 2014