UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001635 |
|---|---|
| Receipt number | 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 09:47:04 |
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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
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
maki@sa2.so-net.ne.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Department of Internal Medicine ,Division or Respiratory Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001965
