Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens
This study has been completed.
Sponsor:
1st Allergy & Clinical Research Center
Collaborator:
Merck
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
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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:
- 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 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.
Contacts and Locations
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
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 May 23, 2013