The Effectiveness of Montelukast on Atopic Dermatitis in Koreans

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Pyun BokYang, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT00903357
First received: May 14, 2009
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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).


Condition Intervention
Atopic Dermatitis
Drug: Montelukast sodium
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Crossover Study to Compare the Effectiveness of Montelukast on Atopic Dermatitis in Koreans

Resource links provided by NLM:


Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Changes in SCORAD Index [ Time Frame: 18 weeks after patient recruitment ] [ Designated as safety issue: Yes ]
    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)

  • Changes in Urinary LTE4 [ Time Frame: 18 weeks after patient recruitment ] [ Designated as safety issue: Yes ]
    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.

  • Changes in Urinary EDN [ Time Frame: 18 weeks after participants recruitment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 54
Study Start Date: August 2009
Study Completion Date: April 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 sodium
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 Name: SINGULAIR
Drug: 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 Name: 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 sodium
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 Name: SINGULAIR
Drug: 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 Name: Ascorbic acid

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

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903357

Locations
Korea, Republic of
Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
Seoul, Korea, Republic of, 140-743
Sponsors and Collaborators
Pyun BokYang
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Bok Yang Pyun, M.D., PhD. Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital
  More Information

No publications provided

Responsible Party: Pyun BokYang, Professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT00903357     History of Changes
Other Study ID Numbers: schallergy
Study First Received: May 14, 2009
Results First Received: July 8, 2011
Last Updated: August 15, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Soonchunhyang University Hospital:
Atopic dermatitis
Montelukast

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Ascorbic Acid
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 18, 2014