The Effectiveness of Montelukast on Atopic Dermatitis in Koreans

November 16, 2015 updated by: Pyun BokYang

A Double Blind, Randomized, Crossover Study to Compare the Effectiveness of Montelukast on Atopic Dermatitis in Koreans

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 140-743
        • Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Montelukast first, then placebo
The group received active medication (montelukast 4 mg or 5mg once daily) for 8 weeks followed by a crossover to 8 weeks of placebo after 2-weeks washout period.
Drug: Montelukast first, then placebo
Patients in "Montelukast first, then placebo" will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in "Placebo first, then Montelukast" are received chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks.
Other Names:
  • SINGULAIR
Drug: Placebo first, then Montelukast
Patients in "Montelukast first, then placebo" will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in "Placebo first, then Montelukast" are received chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks.
Other Names:
  • Ascorbic acid
Experimental: Placebo first, then Montelukast
The group received placebo medication (ascorbic acid) for 8 weeks followed by a crossover to 8 weeks of active medication (montelukast 4 mg or 5mg once daily) after 2-weeks washout period.
Drug: Montelukast first, then placebo
Patients in "Montelukast first, then placebo" will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in "Placebo first, then Montelukast" are received chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks.
Other Names:
  • SINGULAIR
Drug: Placebo first, then Montelukast
Patients in "Montelukast first, then placebo" will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks. And after 2 weeks wash-out period, they will receive chewable ascorbic acid placebo for 8 weeks. Patients in "Placebo first, then Montelukast" are received chewable ascorbic acid placebo for 8 weeks. And after 2 weeks wash-out period, they will receive 4 mg of montelukast under the age of 6 years (5 mg of montelukast at 6 years) once daily for 8 weeks.
Other Names:
  • Ascorbic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in SCORAD Index
Time Frame: 18 weeks after patient recruitment
Changes of SCORAD(SCORing Atopic Dermatitis) index after taking Montelukast or placebo drug. SCORAD calculation: Extent(%)/5 + 7*Intensity/2 + subjective symptoms (minimum score 0, maximum score 103) (SCORAD index >40: severe, 15-40:moderate, <15: mild)
18 weeks after patient recruitment
Changes in Urinary LTE4
Time Frame: 18 weeks after patient recruitment
Changes of Urinary LTE4(Leukotrien E4) after taking Montelukast or placebo drug. Urinary LTE4 levels were measured using an enzyme-linked immunoassay (ELISA) (Cayman Chemical, Michigan, USA) and the intra-assay and inter-assay variations were 7.4 ± 2.1 and 12.4 ± 7.8, respectively. Minimum value : 0 Maximum vlaue: 1000 pg/ml.
18 weeks after patient recruitment
Changes in Urinary EDN
Time Frame: 18 weeks after participants recruitment
Changes of Urinary EDN(Eosinophil Derived Neurotoxin) after taking Montelukast or placebo drug. Urinary EDN levels were measured using an ELISA (MBL, Woburn, MA, USA) and the intra-assay and inter-assay variations were 3.0 ± 0.5 and 7.7 ± 1.5, respectively. Minimum value: 0, Maximum value: 2040 ng/ml.
18 weeks after participants recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pyun BokYang

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Chair: Bok Yang Pyun, M.D., PhD., Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 14, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (Estimate)

May 18, 2009

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • schallergy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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