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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001635
Receipt No. R000001965
Scientific Title Japanese asthma patient's beta2 adrenaline-receptor geno type Arg16Gly cross-over trial about the effect of Salmeterol or Montelukast
Date of disclosure of the study information 2009/01/14
Last modified on 2011/01/14

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Basic information
Public title Japanese asthma patient's beta2 adrenaline-receptor geno type Arg16Gly cross-over trial about the effect of Salmeterol or Montelukast
Acronym J-BLOSSOM
Scientific Title Japanese asthma patient's beta2 adrenaline-receptor geno type Arg16Gly cross-over trial about the effect of Salmeterol or Montelukast
Scientific Title:Acronym J-BLOSSOM
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To compare the efficacy and side effects between long-acting beta2-agonist (salmeterol) and leucotrien receptor antagonist (montelukast) as a role of additional drug to an inhaled corticosteroid (ICS) in Japanese patients with bronchial asthma, based on classification of beta2-adrenergic receptor gene pormorphism (Arg16 Gly), in a prospective, randomized, and cross-over design
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of the change in peak flow values over 4 months between the two groups who will be receiving salmeterol plus Inhaled corticosteroid (ICS) and who will be receiving montelukast plus ICS, based on stratification of beta2-adrenergic receptor gene pormorphism (Arg/Arg vs Gly/Gly)
Key secondary outcomes Comparison of the change in peak flow values between the two groups, (Arg/Arg vs. Gly/Gly) in the period when receiving salmeterol plus ICS

Comparison of the change in peak flow values between the two groups, (Arg/Arg vs. Gly/Gly) in the period when receiving montelukast plus ICS

The other outcome measurements include asthma control test, peripheral eosinophil count, and pulmonary function parameters

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Salmeterol/Montelukast
Interventions/Control_2 Montelukast/Salmeterol
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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients with symptoms such as paroxymal cough or wheezing or dyspnea


Patients with the reversibility of forced expiratory volume in 1 second or airway hyperresponsiveness or patients in an equivalent state judged by respirologists.


Clinically stable patients taking inhaled corticosteroids with/without theophylline.
Key exclusion criteria 1 Patients with allergy to Montelukast or Salmeterol
2 Patients with active respiratory infections
3 Pregnant or lactating patients
4 Patients with smoking index 200 or more than 200,or current smokers
5 Patients with other pulmonary complications.
6 Patients judged to be inappropriate by respirologists.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Nishimura
Organization Hokkaido University Graduate School of Medicine
Division name Department of Internal Medicine ,Division or Respiratory Medicine
Zip code
Address North 15, West 7, Kitaku, Sapporo, Hokkaido, 060-8638
TEL 011-706-5911
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hironi Makita
Organization Institute of Respiratory Cohort Study
Division name Division of bronchial asthma
Zip code
Address Kogin Building,North 1, West 5, Kitaku, Sapporo, 060-0001
TEL 011-207-6771
Homepage URL
Email maki@sa2.so-net.ne.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Department of Internal Medicine ,Division or Respiratory Medicine
Institute
Department

Funding Source
Organization Japan Allergy Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Completed
Date of protocol fixation
2008 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2010 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 01 Month 14 Day
Last modified on
2011 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001965

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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