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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002657
Receipt No. R000003233
Scientific Title Effect of double inhaled corticosteroids in patients with moderate bronchial asthma
Date of disclosure of the study information 2009/11/01
Last modified on 2009/10/22

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Basic information
Public title Effect of double inhaled corticosteroids in patients with moderate bronchial asthma
Acronym Double inhaled corticosteroids on moderate bronchial asthma
Scientific Title Effect of double inhaled corticosteroids in patients with moderate bronchial asthma
Scientific Title:Acronym Double inhaled corticosteroids on moderate bronchial asthma
Region
Japan

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

Objectives
Narrative objectives1 To compare Adoair 500 micro g plus Asmanex 200 micro g and Adoair 1000 micro g in patients with uncontroled moderate bronchial asthma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes exhaled NO
Key secondary outcomes pulmonary functions and peak flow

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Adoair 500 micro g + Asmanex 200 micro g
Interventions/Control_2 Adoair 1000 micro g
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with uncontroled moderate asthma treated with Adoair 250 micro g twice a day.
Key exclusion criteria Cronic disease such as COPD.
Acute disease such as infectious disease.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Kurashima
Organization Saitama cardiovascular and respiratory center
Division name respiratory medicine
Zip code
Address 1696 Itai Kumagaya city, Saitama
TEL 048-536-9900
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyoshi Kurashima
Organization Saitama cardiovascular and respiratory center
Division name respiratory medicine
Zip code
Address 1696 Itai Kumagaya city, Saitama
TEL 048-536-9900
Homepage URL
Email kurashima.kazuyoshi@pref.saitama.lg.jp

Sponsor
Institute Saitama cardiovascular and respiratory center
Institute
Department

Funding Source
Organization Saitama cardiovascular and respiratory center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 埼玉県立循環器・呼吸器病センター

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2009 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 22 Day
Last modified on
2009 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003233

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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