Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens - Full Text View

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 IV

MedlinePlus related topics:

Allergy Food Allergy

ChemIDplus related topics:

Montelukast Montelukast sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parellel Group Study to Evaluate the Efficacy of Montelukast (Singulair) in Participants Ages 1 - 8 Years Diagnosed With Atopic Dermatitis Induced by Food Allergens

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 ]

Secondary Outcome Measures:

The change in serum and urinary inflammatory marker levels [ Time Frame: 9 weeks ]
The change in GRSR validated scale for treating gastrointestinal symptoms induced by food allergens [ Time Frame: 9 weeks ]

Estimated Enrollment:	20
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2008

Arms	Assigned Interventions
1: Experimental	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
2: Placebo Comparator	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:

Mild to moderate atopic dermatitis involving 10-25% of body surface
Total severity score of 4 or greater for any 3 of the 4 signs and symptoms calculated by study doctor (erythema, papulation, or lichenification)
Positive skin or RAST tests by ImmunoCap to food allergens
GI symptoms total score of 8 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.

Contacts and Locations

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

Contacts


Contact: Melinda Heffron, BA	303-224-4678	mheffron@1st-allergy.com

Locations


United States, Colorado
	1st Allergy & Clinical Research Centers	Recruiting
	Centennial, Colorado, United States, 80112
	Contact: Andrea L Beck, MA 303-224-4673 abeck@1st-allergy.com
	1st Allergy & Clinical Research Centers	Recruiting
	Thornton, Colorado, United States, 80229
	Contact: Andrea L Beck, MA 303-224-4673 abeck@1st-allergy.com

Sponsors and Collaborators

1st Allergy & Clinical Research Center

Merck

Investigators


Principal Investigator:	Isaac R Melamed, MD	1st Allergy & Clinical Research Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	32032
First Received:	November 9, 2007
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00557284
Health Authority:	United States: Institutional Review Board

Keywords provided by 1st Allergy & Clinical Research Center:

Atopic Dermatitis (Eczema) associated with food allergies

Study placed in the following topic categories:

Montelukast

Hypersensitivity

Food Hypersensitivity

Dermatitis, Atopic

Genetic Diseases, Inborn

Skin Diseases

Hypersensitivity, Immediate

Skin Diseases, Eczematous

Eczema

Skin Diseases, Genetic

Leukotriene Antagonists

Dermatitis

Additional relevant MeSH terms:

Respiratory System Agents

Immune System Diseases

Therapeutic Uses

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	1st Allergy & Clinical Research Center Merck
Information provided by:	1st Allergy & Clinical Research Center
ClinicalTrials.gov Identifier:	NCT00557284