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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000000926
Receipt No. R000001114
Scientific Title The clinical study whether adult patients with asthma who could withdraw or reduce the treatment of ICSs without exacerbation of disease
Date of disclosure of the study information 2007/12/03
Last modified on 2015/01/06

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Basic information
Public title The clinical study whether adult patients with asthma who could withdraw or reduce the treatment of ICSs without exacerbation of disease
Acronym The clinical study whether adult patients with asthma withdraw or reduce the treatment of ICSs
Scientific Title The clinical study whether adult patients with asthma who could withdraw or reduce the treatment of ICSs without exacerbation of disease
Scientific Title:Acronym The clinical study whether adult patients with asthma withdraw or reduce the treatment of ICSs
Region
Japan

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

Objectives
Narrative objectives1 This study prospectively is investigated whether adult patients with asthma who could withdraw or reduce the treatment of ICSs without exacerbation of disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical symptoms, lung function(FEV1, V50, V25), bronchial hyperresponsiveness, eosinophils in sputum and whole blood cells, IgE
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 continuing of the ICS therapy for same dose
Interventions/Control_2 withdrawing of all ICSs
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 adult patients with asthma achieve without all symptoms more than 6 months after the treatment of ICSs less than FP equivalent 200 mg
Key exclusion criteria adult patients with asthma receive more than FP equivalent 400 mg, or with clinical symptoms less than 6 months
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naomi Tsurikisawa
Organization National Hospital Organization Sagamihara National Hospital
Division name Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1 sakuradai sagamihara
TEL 042-742-8311
Email n-tsurikisawa@sagamihara-hosp.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Tsurikisawa
Organization National Hospital Organization Sagamihara National Hospital
Division name Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1 Sakuradai Minami-ku Sagamihara Kanagawa
TEL 042-742-8311
Homepage URL
Email n-tsurikisawa@sagamihara-hosp.gr.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2007 Year 12 Month 03 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 Enrolling by invitation
Date of protocol fixation
2007 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2013 Year 03 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
2007 Year 12 Month 03 Day
Last modified on
2015 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001114

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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