UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056987 |
|---|---|
| Receipt number | R000065128 |
| Scientific Title | Impact of Biologics for Recovering Outcomes and Improving Productivity Goodness in High-risk Trajectory cohort of Severe Pediatric and Young Adult Severe Asthma Study |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/02/10 11:29:40 |
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Basic information
Public title
Impact of Biologics for Recovering Outcomes and Improving Productivity Goodness in High-risk Trajectory cohort of Severe Pediatric and Young Adult Severe Asthma Study
Acronym
BRIGHT Study
Scientific Title
Impact of Biologics for Recovering Outcomes and Improving Productivity Goodness in High-risk Trajectory cohort of Severe Pediatric and Young Adult Severe Asthma Study
Scientific Title:Acronym
BRIGHT Study
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the long-term outcomes (clinical, pathophysiological, and health economic) of biologics in moderate-to-severe asthma and to identify factors associated with remission (both under treatment and post-treatment). Furthermore, to quantify the societal value of biologics through a cost-effectiveness analysis that considers productivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Proportion of patients achieving clinical remission
2.Longitudinal changes in pulmonary function
3.Morphological assessment via high-resolution computed tomography (HRCT)
4.Health economic evaluation, including productivity considerations
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
| 6 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Study Group (Target1): Participants must meet all three of the following criteria:
Asthma patients aged between 6 and 50 years.
Patients experiencing uncontrolled asthma or exacerbations requiring systemic corticosteroid treatmentdespite the use of medium- or high-dose inhaled corticosteroids (ICS) in combination with other long-term controller medications, and who are eligiblefor biologic therapy under health insurance coverage.
Patients who are either currently receiving biologic therapy* at the time of enrollment or have been scheduled to initiate biologic therapy.
Control Group (Target2): Participants must meet all three of the following criteria (serving as the comparator to Target 1):
Asthma patients aged between 6 and 50 years.
Patients experiencing uncontrolled asthma or exacerbations requiring systemiccorticosteroid treatment despite the use of medium- or high-dose ICS in combination with other long-term controller medications, or those exhibiting aprogressive decline in pulmonary function over time.
Patients who have not received biologic therapy* for asthma at the time of enrollment and do not haveimmediate plans to initiate such treatment.
* Biologic therapy refers to any of the following monoclonal antibodies: Omalizumab, Mepolizumab, Benralizumab, Dupilumab, Tezepelumab
Key exclusion criteria
Participants meeting any of the following criteria will be excluded from the study:
Patientsreceiving (or scheduled to receive) any of the aforementioned biologic agents* for indications other than asthma** under health insurance coverage.Patients currently receiving (or scheduled to receive) immunosuppressive agents other than corticosteroids, such as oral Janus kinase (JAK)inhibitors or oral calcineurin inhibitors.
Patients diagnosed with autoimmune diseases or malignancies at the time of enrollment (cases in which theseconditions newly develop during the observation period will not be excluded).Cases deemed inappropriate for study participation by the principal investigator or co-investigators.
* Biologic agents include omalizumab,mepolizumab, benralizumab, dupilumab, and tezepelumab.
** Non-asthma indications include chronic spontaneous urticaria, seasonal allergicrhinitis, eosinophilic granulomatosis with polyangiitis, atopic dermatitis, chronic rhinosinusitis with nasal polyps, and nodular prurigo.
Target sample size
200
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
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
0592322531
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
| 2025 | Year | 02 | Month | 10 | 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
| 2024 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 02 | Month | 10 | 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=R000065128
