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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002219
Receipt No. 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

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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
Condition Bronchial asthma
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

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 2
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
Institute Le-PAT study group
Institute
Department

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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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
URL(English) https://upload.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


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