Clinical trial NCT00903357: The Effectiveness of Montelukast on Atopic Dermatitis in Koreans
Official title: A Double Blind, Randomized, Crossover Study to Compare the Effectiveness of Montelukast on Atopic Dermatitis in Koreans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Montelukast
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-05-18
Enrollment: 54
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the clinical effectiveness of Montelukast in children (2\~6 years old) with atopic dermatitis and identify the pathophysiologic background of Montelukast on the role of modulating the atopic dermatitis measured by urinary Leukotriene 4 (LTE4) and Eosinophil protein X(EDN).

Detailed description: Leukotriene B4 (LTB4) and the cysteinyl-leukotrienes LTC4, LTD4 and LTE4 are potent proinflammatory mediators derived from arachidonic acid through the 5- lipoxygenase pathway. They are secreted from eosinophils and other inflammatory cells such as mast cells and macrophages. The primary action of leukotrienes includes contraction of human airway muscle, chemotaxis, and increased vascular permeability, with secondary effects of inhibiting allergen-induced early and late responses. Several in vivo and in vitro studies suggest a role for cysteinyl leukotrienes in the pathogenesis of atopic dermatitis and there is a rationale for the use of pharmacological agents to antagonize their effects in the treatment of atopic dermatitis. Levels of LTE4 measured in urine (Urinary-LTE4) may be a useful measure of whole-body cysteinyl-leukotriene production in vivo, because that LTE4 is a stable urinary metabolite of LTC4 and LTD4. Urinary-LTE4 has been measured in individuals with atopic dermatitis, but in small-scale studies, and the results are conflicting.

Eligibility criteria: Inclusion Criteria:

* The ages of 2 to 6 years old, 54 children with moderate to severe atopic dermatitis diagnosed by the criteria of Haniffin and Rajka were included in the study.
* Volunteer children with moderate to severe atopic dermatitis were recruited from the Pediatric Allergy and respiratory Center of the SoonChunHyang University Hospital (Seoul, Korea). At the time of recruitment, written consent was obtained. The ethical committee at the SoonChunHyang University Hospital approved the trial.
* Volunteers who agreed by their parents.
* The severity of their disease was assessed by modified SCORAD index.

Exclusion Criteria:

* Too severe atopic dermatitis defined as the sum of scores is 80 and above by SCORAD index.
* A history of liver disease; allergy to montelukast or cross-reacting medication; use of phenobarbital, phenytoin or rifampicin.
* Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks.

Primary outcomes:
measure: Changes in SCORAD Index
timeFrame: 18 weeks after patient recruitment
measure: Changes in Urinary LTE4
timeFrame: 18 weeks after patient recruitment
measure: Changes in Urinary EDN
timeFrame: 18 weeks after participants recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
Study officials:
affiliation: Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
name: Bok Yang Pyun, M.D., PhD.
role: STUDY_CHAIR
References: