UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038873 |
|---|---|
| Receipt number | R000044329 |
| Scientific Title | Study of dupilumab administration for refractory adulthood asthma |
| Date of disclosure of the study information | 2019/12/13 |
| Last modified on | 2022/12/15 18:26:07 |
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Basic information
Public title
Study of dupilumab administration for refractory adulthood asthma
Acronym
Study of dupilumab administration for refractory adulthood asthma
Scientific Title
Study of dupilumab administration for refractory adulthood asthma
Scientific Title:Acronym
Study of dupilumab administration for refractory adulthood asthma
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study on efficacy of dupilumab and identification of clinical predictive biomarkers for refractory asthma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in symptom score occured 1 to 4 months after administration of dupilumab
Key secondary outcomes
Change in lung function test
Change in inflammatory markers
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with bronchial asthma in Sagamihara hospital
2. Patients who obtain written consent regarding the participation of this study
Key exclusion criteria
1. The sensitivity to multiple drugs
2. Women who is pregnancy or breast feeding
3. Patients who joins other clinical trial study
4. Patients judged unsuitable as subjects by doctor's judgment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Kamide |
Organization
Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL
042-742-8311
m08702012@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Kamide |
Organization
Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL
042-742-8311
Homepage URL
m08702012@gunma-u.ac.jp
Sponsor or person
Institute
Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sagamihara National Hospital
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
Tel
042-742-8311
222-rinri@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 13 | Day |
Related information
URL releasing protocol
Currently being analyzed
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Study design: Observarional study
Study duration:from 2019/5/21 to 2024/3/31
Subjects:All subjects that our hospital visited by refractory asthma, and met the selection criteria.
Management information
Registered date
| 2019 | Year | 12 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044329
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
