UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000926 |
|---|---|
| Receipt number | 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 13:44:44 |
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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
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
n-tsurikisawa@sagamihara-hosp.gr.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001114
