UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000002219
Receipt number	R000002724
Scientific Title	Efficacy of JPGL-based controller therapy with montelukast for early mild asthma
Date of disclosure of the study information	2009/07/19
Last modified on	2017/07/22 21:40:55

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Basic information

Public title

Efficacy of JPGL-based controller therapy with montelukast for early mild asthma

Acronym

J-COME study

Scientific Title

Efficacy of JPGL-based controller therapy with montelukast for early mild asthma

Scientific Title:Acronym

J-COME study

Region

Japan

Condition

Bronchial asthma

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Explore efficacy of a leukotriene receptor antagonist, montelukast, for mild asthma in preschool children

Basic objectives2

Others

Basic objectives -Others

Japanese Pediatric Guideline for the treatment and management of asthma (JPGL) recommends leukotriene receptor antagonists for mild asthma in preschool children. Since gradings of asthma severity are different between JPGL and other guidelines including the international guideline, GINA, JPGL recomends to start treatment earlier to milder asthma than GINA and other foreign guidelines do. Efficacy of JPGL-based treatment, however, has not been proved and has to be investigated.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Assessment

Primary outcomes

Number of asthma exacerbation episodes

Key secondary outcomes

1) Time to first asthma exacerbation
2) Time to loss of asthma control that needs inhaled corticosteroids
3) Symptom-free days

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Montelukast + on demand use of beta2 agonists

Interventions/Control_2

on demand use of beta2 agonists

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

1 years-old <=

Age-upper limit

6 years-old >

Gender

Male and Female

Key inclusion criteria

children with asthma symptoms more than once a month and less than once a week, which is graded as mild persistent in JPGL.
2-5 years old: diagnosis of asthma is based on JPGL.
1 years old: category A + one of category B
Category A: improvement of wheezing, dyspnea, or oxygen saturation after inhalation of a short-acting beta2 agonist
Category B: 1 physician-diagnosed atopic dermatitis, 2 physician-diagnosed food allergy, 3 physician-diagnosed parental asthma

Key exclusion criteria

1 use of anti-allergics within 6 months before enrollment (cromolyns, anti-histamines, suplatast, montelukast, pranlukast)
2 use of inhaled and systemic corticosteroids within 6 months before enrollment
3 use of theophylline within 6 months before enrollment
4 hypersensitivity to montelukast
5 use of long-acting beta2 agonists within 6 months before enrollment (permit short-term use of tuloburol patch)
6 conditions that a responsible investigator judges inapproriate

Target sample size

100

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Takao Fujisawa

Organization

Mie National Hospital

Division name

Institute for Clinical Research

Zip code

Address

357 Ostao-kubota, Tsu, Mie, Japan

TEL

059-232-2531

Email

fujisawa@mie-m.hosp.go.jp

Public contact

Name of contact person

1st name

Middle name

Last name Mizuho Nagao

Organization

Mie National Hospital

Division name

Institute for Clinical Research

Zip code

Address

357 Osato-kubota, Tsu, Mie 514-0125, Japan

TEL

059--2531

Homepage URL

Email

nagaomizuho@mie-m.hosp.go.jp

Sponsor or person

Institute

Le-PAT study group

Institute

Department

Personal name

Funding Source

Organization

The Waksman Foundation of Japan, INC

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

The Waksman Foundation of Japan, INC

Name of secondary funder(s)

The Waksman Foundation of Japan, INC

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2009 Year 07 Month 19 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

http://www.allergologyinternational.com/article/S1323-8930(17)30049-7/fulltext

Number of participants that the trial has enrolled

Results

Background:While Japanese guideline recommends initial control treatment for preschool children with asthma symptoms more than once a month, Western guidelines do not. To determine whether control treatment with montelukast was more effective than as-needed beta2-agonists in this population, we conducted a randomized controlled trial.
Methods:Eligible patients were children aged 1 to 5 years who had asthma symptoms more than once a month but less than once a week. Patients were randomly assigned in a 1:1 ratio to receive montelukast 4 mg daily for 48 weeks or as-needed beta2-agonists. The primary endpoint was the number of acute asthma exacerbations before starting step-up treatment with inhaled corticosteroids. This study is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000002219.
Results:From September 2009 to November 2012, 93 patients (47 in the montelukast group and 46 in the no-controller group) were enrolled into the study. All patients were included in the analysis. During the study, 13 patients (28%) in the montelukast group and 23 patients (50%) in the no-controller group had acute exacerbations with the mean numbers of 0.9 and 1.9/year, respectively (P = 0.027). In addition, 10 (21%) and 19 (41%) patients received step-up treatment, respectively. Cumulative incidence of step-up treatment was significantly lower in the montelukast group (hazard ratio 0.45, 95% confidence interval 0.21 to 0.92; P = 0.033).
Conclusions:Montelukast is an effective control treatment for preschool children who had asthma symptoms more than once a month but less than a week.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Main results already published

Date of protocol fixation

2009 Year 07 Month 18 Day

Date of IRB

Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2013 Year 07 Month 01 Day

Date of closure to data entry

2013 Year 10 Month 01 Day

Date trial data considered complete

2013 Year 10 Month 01 Day

Date analysis concluded

2014 Year 12 Month 01 Day

Other

Other related information

Management information

Registered date

2009 Year 07 Month 17 Day

Last modified on

2017 Year 07 Month 22 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002724

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name