UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038669 |
|---|---|
| Receipt number | R000044073 |
| Scientific Title | Comprehensive efficacy of anti interleukin-4 receptor alpha antibody in patients with severe asthma |
| Date of disclosure of the study information | 2019/11/25 |
| Last modified on | 2024/11/27 17:11:15 |
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Basic information
Public title
Comprehensive efficacy of anti interleukin-4 receptor alpha antibody in patients with severe asthma
Acronym
efficacy of anti interleukin-4 receptor alpha antibody in severe asthma
Scientific Title
Comprehensive efficacy of anti interleukin-4 receptor alpha antibody in patients with severe asthma
Scientific Title:Acronym
efficacy of anti interleukin-4 receptor alpha antibody in severe asthma
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of anti interleukin-4 receptor alpha antibody in patients with severe asthma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cough and sputum related questionnaire score
biomarker of induced sputum
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with asthma.
patients whose asthma has not been well controlled despite high doses of inhaled cotricosteroid and maintenance treatment.
patients who consent to the study.
Key exclusion criteria
patients who have other respiratory diseases.
patients who have a history of smoking more than 10 pack-year.
patients who are pregnant or nurse.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Tajiri |
Organization
Nagoya City University
Division name
Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8216
tomokot@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Tajiri |
Organization
Nagoya City University
Division name
Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8216
Homepage URL
tomokot@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University
Address
1 Kawasymi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
052-858-7215
tomokot@med.nagoya-cu.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 09 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We assesse the efficacy 6 months after the treatment. In responders, we assess the efficacy 12 months after the treatment.
Management information
Registered date
| 2019 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044073
