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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Montelukast |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 9 weeks |
| Mean Change in Investigator Global Assessment (IGA) | 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. | Baseline and 9 weeks |
| Mean Change in PADC (Caregivers Perception of Disease Control) | 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) | Baseline and 9 weeks |
| Mean Change in Pruritus | 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. | Baseline and 9 weeks |
| Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Serum and Urinary Inflammatory Marker Levels | 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) | Baseline and 9 weeks |
| Mean Change in Serum IgE Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isaac R Melamed, MD | 1st Allergy & Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Allergy & Clinical Research Centers | Centennial | Colorado | 80112 | United States | ||
| 1st Allergy & Clinical Research Centers |
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| Label | URL |
|---|---|
| Research website | View source |
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Thirty-three subjects were screened for the trial; 20 subjects met all inclusion and exclusion criteria; 13 failed to meet all inclusion criteria.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo Arm | Placebo : Oral granules or chewable tablet, POQD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Change in Serum and Urinary Inflammatory Marker Levels | 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) | Posted | Mean | Standard Deviation | pg/ml | Baseline and 9 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Isaac Melamed, principle investigator | IMMUNOe International Research Centers | 303-773-9000 | melamedi@immunoe.com |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Placebo | Drug | Oral granules or chewable tablet, PO QD (given oral daily) |
|
| 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. |
| Baseline and 9 weeks |
| Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS | 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). | Baseline and 9 weeks |
| Thornton |
| Colorado |
| 80229 |
| United States |
Placebo : Oral granules or chewable tablet, POQD
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Percentage of Body Involvement | Percentage of body surface as calculated by investigator. Measurement is mean for all subjects in each arm. | Mean | Standard Deviation | percentage |
|
| Investigator Global Assessment (IGA) | The IGA is a six-point measure of disease severity are evaluated by the study doctor based on the overall assessment of skin lesions: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5= very severe. Measurement is the mean for all subjects in each arm. | Mean | Standard Deviation | Scores on a scale |
|
| PADC (caregivers assessment of disease control) | 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). Measurement is the mean for all subjects in each arm. | Mean | Standard Deviation | Scores on a scale |
|
| Pruritus score | Pruritus assessments ("itch") will be recorded for the previous 24 hours using a 4 point-scale, ranging from none (0) to severe (3). Measurement is mean of all subjects in each arm. | Mean | Standard Deviation | units on a scale |
|
| IL-13 | Serum interleukin 13 levels. Measurement is the mean for all subjects in each arm. | Mean | Standard Deviation | pg/ml |
|
| TNF alpha | Serum Tumor Necrosis Factor levels. Measurement is the mean for all subjects in each arm. | Mean | Standard Deviation | pg/ml |
|
| NGF | Serum Nerve Growth Factor levels. Measurement is the mean for all subjects in each arm. | Mean | Standard Deviation | pg/ml |
|
| Urine LTE4 | Urine Cysteinyl leukotriene 4 levels. Measurement is the mean for all subjects in each arm. | Mean | Standard Deviation | pg/ml |
|
| IgE | Serum Immunoglobulin E levels. Measurement is the mean for all subjects in each arm. | Mean | Standard Deviation | kU/L |
|
| GSRS | GI symptoms will be recorded weekly on *GSRS validated scale adjusted for pediatrics (*Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome and Peptic Ulcer Disease). 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 (maximum total of 21 - most severe). Measurement is the mean for all subjects in each arm. | Mean | Standard Deviation | Scores on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Mean Change in Serum IgE Levels | 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. | Posted | Mean | Standard Deviation | kU/L | Baseline and 9 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Change of percentage in body involvement | Baseline and 9 weeks |
|
|
|
| Primary | Mean Change in Investigator Global Assessment (IGA) | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 weeks |
|
|
|
| Primary | Mean Change in PADC (Caregivers Perception of Disease Control) | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 weeks |
|
|
|
| Primary | Mean Change in Pruritus | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 weeks |
|
|
|
| Primary | Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream | 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). | Posted | Mean | Standard Deviation | days/week | Baseline and 9 weeks |
|
|
|
| Secondary | Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Placebo Arm | Placebo : Oral granules or chewable tablet, POQD | 0 | 11 | 0 | 11 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |