UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040839 |
|---|---|
| Receipt number | R000046627 |
| Scientific Title | Study on the effects of long-term respiratory function prognosis in bronchial asthma |
| Date of disclosure of the study information | 2020/06/22 |
| Last modified on | 2020/06/20 16:45:50 |
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Basic information
Public title
Study on the effects of long-term respiratory function prognosis in bronchial asthma
Acronym
Study on the effects of long-term respiratory function prognosis in bronchial asthma
Scientific Title
Study on the effects of long-term respiratory function prognosis in bronchial asthma
Scientific Title:Acronym
Study on the effects of long-term respiratory function prognosis in bronchial asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of long-term treatment prognosis on patients with asthma based on physiological items.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulmonary function at baseline, after 1, 3 and 5 years.
Key secondary outcomes
Peripheral blood, IgE, FeNO, CT findings, Asthma control questionnaire, Quality of life questionnaire, Therapeutic agents
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who can obtain informed consent to participate in research.
Key exclusion criteria
Women who are pregnant or may be pregnant.
Patients with other serious complication diseases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hoshino |
| Middle name | |
| Last name | Makoto |
Organization
Atami Hospital, International University of Health and Welfare
Division name
Division of Clinical Allergy
Zip code
413-0012
Address
13-1 Higashikaigan-cho, Atami, Shizuoka
TEL
0557-81-9171
hoshino@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hoshino |
| Middle name | |
| Last name | Makoto |
Organization
Atami Hospital, International University of Health and Welfare
Division name
Division of Clinical Allergy
Zip code
413-0012
Address
13-1 Higashikaigan-cho, Atami, Shizuoka
TEL
0557-81-9171
Homepage URL
hoshino@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Atami Hospital, International University of Health and Welfare
Address
13-1 Higashikaigan-cho, Atami, Shizuoka
Tel
0557-81-9171
na-ayumi@iuhw.ac.jp
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
国際医療福祉大学熱海病院(静岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 22 | 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
| 2020 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 06 | Month | 20 | Day |
Last modified on
| 2020 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046627
