Trial Outcomes & Findings for Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens (NCT NCT00557284)

NCT ID: NCT00557284

Last Updated: 2015-04-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 9 weeks

Results posted on

2015-04-21

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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	Placebo Arm Placebo : Oral granules or chewable tablet, POQD
Overall Study STARTED	9	11
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=9 Participants 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 Arm n=11 Participants Placebo : Oral granules or chewable tablet, POQD	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	5.5 years STANDARD_DEVIATION 2.3 • n=5 Participants	5.6 years STANDARD_DEVIATION 1.7 • n=7 Participants	5.5 years STANDARD_DEVIATION 2.0 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants
Percentage of Body Involvement	21.67 percentage STANDARD_DEVIATION 8.9 • n=5 Participants	20.05 percentage STANDARD_DEVIATION 8.1 • n=7 Participants	20.86 percentage STANDARD_DEVIATION 8.5 • n=5 Participants
Investigator Global Assessment (IGA)	2.11 Scores on a scale STANDARD_DEVIATION 0.33 • n=5 Participants	2.30 Scores on a scale STANDARD_DEVIATION 0.48 • n=7 Participants	2.20 Scores on a scale STANDARD_DEVIATION 0.40 • n=5 Participants
PADC (caregivers assessment of disease control)	1.78 Scores on a scale STANDARD_DEVIATION 0.67 • n=5 Participants	1.80 Scores on a scale STANDARD_DEVIATION 0.92 • n=7 Participants	1.79 Scores on a scale STANDARD_DEVIATION 0.80 • n=5 Participants
Pruritus score	1.60 units on a scale STANDARD_DEVIATION 0.79 • n=5 Participants	1.17 units on a scale STANDARD_DEVIATION 0.72 • n=7 Participants	1.36 units on a scale STANDARD_DEVIATION 0.30 • n=5 Participants
IL-13	33.67 pg/ml STANDARD_DEVIATION 30.20 • n=5 Participants	34.70 pg/ml STANDARD_DEVIATION 37.0 • n=7 Participants	34.18 pg/ml STANDARD_DEVIATION 33.60 • n=5 Participants
TNF alpha	1.87 pg/ml STANDARD_DEVIATION 0.87 • n=5 Participants	5.70 pg/ml STANDARD_DEVIATION 11.03 • n=7 Participants	3.78 pg/ml STANDARD_DEVIATION 5.95 • n=5 Participants
NGF	99.78 pg/ml STANDARD_DEVIATION 167.38 • n=5 Participants	108.70 pg/ml STANDARD_DEVIATION 192.35 • n=7 Participants	104.24 pg/ml STANDARD_DEVIATION 179.86 • n=5 Participants
Urine LTE4	52.90 pg/ml STANDARD_DEVIATION 40.20 • n=5 Participants	66.65 pg/ml STANDARD_DEVIATION 62.90 • n=7 Participants	59.77 pg/ml STANDARD_DEVIATION 51.55 • n=5 Participants
IgE	432.20 kU/L STANDARD_DEVIATION 887.90 • n=5 Participants	392.40 kU/L STANDARD_DEVIATION 441.00 • n=7 Participants	412.30 kU/L STANDARD_DEVIATION 664.45 • n=5 Participants
GSRS	4.67 Scores on a scale STANDARD_DEVIATION 2.5 • n=5 Participants	5.0 Scores on a scale STANDARD_DEVIATION 2.4 • n=7 Participants	4.83 Scores on a scale STANDARD_DEVIATION 2.45 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants 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 Arm n=11 Participants Placebo : Oral granules or chewable tablet, POQD
Change in Percentage of Body Involvement	-2.0 Change of percentage in body involvement Standard Deviation 12.2	0.15 Change of percentage in body involvement Standard Deviation 20.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants 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 Arm n=11 Participants Placebo : Oral granules or chewable tablet, POQD
Mean Change in Investigator Global Assessment (IGA)	-.11 units on a scale Standard Deviation 1.7	-.70 units on a scale Standard Deviation .95

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants 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 Arm n=11 Participants Placebo : Oral granules or chewable tablet, POQD
Mean Change in PADC (Caregivers Perception of Disease Control)	-.78 units on a scale Standard Deviation 1.1	-0.10 units on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants 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 Arm n=11 Participants Placebo : Oral granules or chewable tablet, POQD
Mean Change in Pruritus	-0.82 units on a scale Standard Deviation 0.78	0.32 units on a scale Standard Deviation 0.45

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants 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 Arm n=11 Participants Placebo : Oral granules or chewable tablet, POQD
Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream Cetirizine use	-0.56 days/week Standard Deviation 0.88	0.91 days/week Standard Deviation 2.1
Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream 10% Hydrocortisone cream use	0.78 days/week Standard Deviation 2.7	2.0 days/week Standard Deviation 3.3

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants 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 Arm n=11 Participants Placebo : Oral granules or chewable tablet, POQD
Mean Change in Serum and Urinary Inflammatory Marker Levels IL3	-9.0 pg/ml Standard Deviation 43.9	-7.9 pg/ml Standard Deviation 53.7
Mean Change in Serum and Urinary Inflammatory Marker Levels TNF alpha	2.3 pg/ml Standard Deviation 5.5	-16.4 pg/ml Standard Deviation 13.6
Mean Change in Serum and Urinary Inflammatory Marker Levels NGF	30.9 pg/ml Standard Deviation 306.7	-58.8 pg/ml Standard Deviation 198.3
Mean Change in Serum and Urinary Inflammatory Marker Levels Urine LTE4	-2.1 pg/ml Standard Deviation 46.2	-20.42 pg/ml Standard Deviation 65.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants 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 Arm n=11 Participants Placebo : Oral granules or chewable tablet, POQD
Mean Change in Serum IgE Levels	100.5 kU/L Standard Deviation 355.6	216.1 kU/L Standard Deviation 505.9

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants 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 Arm n=11 Participants Placebo : Oral granules or chewable tablet, POQD
Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS	-3.03 units on a scale Standard Deviation 3.1	-4.1 units on a scale Standard Deviation 3.1

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Isaac Melamed, principle investigator

IMMUNOe International Research Centers

Phone: 303-773-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place