The Effectiveness of Montelukast on Atopic Dermatitis in Koreans

NCT00903357 | Completed Results DMC

• 1 other identifier: schallergy
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Montelukast

Outcome Measures

Primary Outcomes (3)

• Changes in SCORAD Index

  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

  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

  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

Study Arms (2)

Montelukast first, then placebo

EXPERIMENTAL

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; Drug: Placebo first, then Montelukast

Placebo first, then Montelukast

EXPERIMENTAL

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; Drug: Placebo first, then Montelukast

Interventions

Montelukast first, then placebo DRUG

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.

Also known as: SINGULAIR

Montelukast first, then placebo; Placebo first, then Montelukast

Placebo first, then Montelukast DRUG

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.

Also known as: Ascorbic acid

Montelukast first, then placebo; Placebo first, then Montelukast

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pyun BokYang: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital

Seoul, 140-743, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

montelukast; Ascorbic Acid

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Bok Yang Pyun, M.D.
• Organization: Department of Pediatrics, Soonchunhyang University Hospital

bypyun@hanmail.net

+82-2-709-9339

Study Officials

• Bok Yang Pyun, M.D., PhD.

  Pediatric Allergy & Respiratory Center, Department of Pediatrics, Soonchunhyang University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 18, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: April 1, 2011
• Last Updated: December 14, 2015
• Results First Posted: September 13, 2012

Record last verified: 2015-11

Locations

KR (1)