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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003148
Receipt No. R000003819
Scientific Title A multicenter study of the clinical evaluations of inhaled corticosteroids for bronchial asthma.
Date of disclosure of the study information 2010/02/08
Last modified on 2010/02/08

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Basic information
Public title A multicenter study of the clinical evaluations of inhaled corticosteroids for bronchial asthma.
Acronym The multicenter study of inhaled corticosteroids for asthma.
Scientific Title A multicenter study of the clinical evaluations of inhaled corticosteroids for bronchial asthma.
Scientific Title:Acronym The multicenter study of inhaled corticosteroids for asthma.
Region
Japan

Condition
Condition asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluation of clinical effects and adherence for inhaled corticoseroids due to devices
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes control level of asthma
Key secondary outcomes marker for bronchia inflammation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 change devices of inhaled corticosteroids
Interventions/Control_2
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
15 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria adult asthma
Key exclusion criteria drug sensitivity
bronchial infection
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikkou Higashimoto
Organization Kagoshima university hospital
Division name respiratory medicine
Zip code
Address sakuragaoka8-35-1, Kagoshima city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ikkou Higashimoto
Organization Kaogoshima university hospital
Division name respiratory medicine
Zip code
Address
TEL
Homepage URL
Email ikkou@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima university hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2010 Year 02 Month 08 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 Open public recruiting
Date of protocol fixation
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 08 Day
Last modified on
2010 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003819

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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