UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050429 |
|---|---|
| Receipt number | R000057434 |
| Scientific Title | A prospective cohort study of treatment efficacy of biologics for severe asthma in children and young adults for prevention of airway remodeling |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2025/02/10 10:57:37 |
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Basic information
Public title
A prospective cohort study of treatment efficacy of biologics for severe asthma in children and young adults for prevention of airway remodeling
Acronym
A prospective cohort study of treatment efficacy of biologics for severe asthma in children and young adults for prevention of airway remodeling
Scientific Title
A prospective cohort study of treatment efficacy of biologics for severe asthma in children and young adults for prevention of airway remodeling
Scientific Title:Acronym
A prospective cohort study of treatment efficacy of biologics for severe asthma in children and young adults for prevention of airway remodeling
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the efficacy of biologics in the treatment of severe asthma in children and young adults, with a focus on improving respiratory function and preventing the development of airway remodeling.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in respiratory function before and after administration of each biologic
Key secondary outcomes
1. Changes in Clinical Symptoms Before and After Introduction of Biological Agents
2. Biomarker changes before and after introduction of biologics
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
| 6 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with asthma between the ages of 6 and 39 years who require the administration of a biologics.
2) Those whose FEV1, FEV1/FVC, and V50 have been measured at least once a year, and at least 3 times in the last 2 years.
Key exclusion criteria
1) Those who have already started and are stable on the use of the following biologics.(omalizumab, mepolizumab, venlalizumab, dupilumab, tezepelumab)
2) Those who have requested to opt out of this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Nishida |
Organization
National Mie Hospital
Division name
Department of Pediatrics and Allergy
Zip code
514-0125
Address
357 Osato-Kubota-cho, Tsu City, Mie
TEL
059-232-2531
t_nishida0930@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Nishida |
Organization
National Mie Hospital
Division name
Department of Pediatrics and Allergy
Zip code
514-0125
Address
357 Osato-Kubota-cho, Tsu City, Mie
TEL
059-232-2531
Homepage URL
t_nishida0930@yahoo.co.jp
Sponsor or person
Institute
National Mie Hospital
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gunma University School of Medicine
Sagamihara National Hospital
Fukuoka National Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Mie Hospital Ethics board
Address
357 Osato-Kubota-cho, Tsu City, Mie
Tel
059-232-2531
t_nishida0930@yahoo.co.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
| 2023 | Year | 03 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2023 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057434
