Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557284

Enrollment

Registered

2007-11-12

Start date

2008-03-31

Completion date

2009-05-31

Last updated

2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis (Eczema) associated with food allergies

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.

Interventions

DRUGMontelukast

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

DRUGPlacebo

Oral granules or chewable tablet, PO QD (given oral daily)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to 8 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream	Baseline and 9 weeks	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).
Mean Change in Investigator Global Assessment (IGA)	Baseline and 9 weeks	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)	Baseline and 9 weeks	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	Baseline and 9 weeks	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.
Change in Percentage of Body Involvement	Baseline and 9 weeks	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

Secondary

Measure	Time frame	Description
Mean Change in Serum IgE Levels	Baseline and 9 weeks	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	Baseline and 9 weeks	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).
Mean Change in Serum and Urinary Inflammatory Marker Levels	Baseline and 9 weeks	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)

Countries

United States

Participant flow

Recruitment details

The study was conducted at 2 outpatient clinics in the Denver, Colorado, metropolitan area between February 2008 and March 2009. Individual subject participation lasted for approximately 9 weeks.

Pre-assignment details

Thirty-three subjects were screened for the trial; 20 subjects met all inclusion and exclusion criteria; 13 failed to meet all inclusion criteria.

Participants by arm

Arm	Count
Treatment Arm 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	9
Placebo Arm Placebo : Oral granules or chewable tablet, POQD	11
Total	20

Baseline characteristics

Characteristic	Total	Placebo Arm	Treatment Arm
Age, Categorical <=18 years	20 Participants	11 Participants	9 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	5.5 years STANDARD_DEVIATION 2	5.6 years STANDARD_DEVIATION 1.7	5.5 years STANDARD_DEVIATION 2.3
GSRS	4.83 Scores on a scale STANDARD_DEVIATION 2.45	5.0 Scores on a scale STANDARD_DEVIATION 2.4	4.67 Scores on a scale STANDARD_DEVIATION 2.5
IgE	412.30 kU/L STANDARD_DEVIATION 664.45	392.40 kU/L STANDARD_DEVIATION 441	432.20 kU/L STANDARD_DEVIATION 887.9
IL-13	34.18 pg/ml STANDARD_DEVIATION 33.6	34.70 pg/ml STANDARD_DEVIATION 37	33.67 pg/ml STANDARD_DEVIATION 30.2
Investigator Global Assessment (IGA)	2.20 Scores on a scale STANDARD_DEVIATION 0.4	2.30 Scores on a scale STANDARD_DEVIATION 0.48	2.11 Scores on a scale STANDARD_DEVIATION 0.33
NGF	104.24 pg/ml STANDARD_DEVIATION 179.86	108.70 pg/ml STANDARD_DEVIATION 192.35	99.78 pg/ml STANDARD_DEVIATION 167.38
PADC (caregivers assessment of disease control)	1.79 Scores on a scale STANDARD_DEVIATION 0.8	1.80 Scores on a scale STANDARD_DEVIATION 0.92	1.78 Scores on a scale STANDARD_DEVIATION 0.67
Percentage of Body Involvement	20.86 percentage STANDARD_DEVIATION 8.5	20.05 percentage STANDARD_DEVIATION 8.1	21.67 percentage STANDARD_DEVIATION 8.9
Pruritus score	1.36 units on a scale STANDARD_DEVIATION 0.3	1.17 units on a scale STANDARD_DEVIATION 0.72	1.60 units on a scale STANDARD_DEVIATION 0.79
Region of Enrollment United States	20 participants	11 participants	9 participants
Sex: Female, Male Female	10 Participants	5 Participants	5 Participants
Sex: Female, Male Male	10 Participants	6 Participants	4 Participants
TNF alpha	3.78 pg/ml STANDARD_DEVIATION 5.95	5.70 pg/ml STANDARD_DEVIATION 11.03	1.87 pg/ml STANDARD_DEVIATION 0.87
Urine LTE4	59.77 pg/ml STANDARD_DEVIATION 51.55	66.65 pg/ml STANDARD_DEVIATION 62.9	52.90 pg/ml STANDARD_DEVIATION 40.2

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 9	0 / 11
serious Total, serious adverse events	0 / 9	0 / 11

Outcome results

Primary

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