UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060530 |
|---|---|
| Receipt number | R000069244 |
| Scientific Title | Clinical Background of Patients with Severe Asthma who Discontinued Biologics: A Multi-center Observational Study |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2026/01/30 20:26:58 |
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Basic information
Public title
Survey on the Background of Asthma Patients Who Discontinued Biological Agents
Acronym
Asthma Post-Biologics Study
Scientific Title
Clinical Background of Patients with Severe Asthma who Discontinued Biologics: A Multi-center Observational Study
Scientific Title:Acronym
Study on Discontinued Biologics in Asthma
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary Endpoint
The primary objective is to investigate the main reasons for discontinuing biologic agents through a questionnaire.
Secondary Endpoints
Duration of biologic agent use, type of agent used, and whether self-injection was performed.
Use of maintenance or intermittent oral corticosteroids (OCS).
ACT scores at initiation and discontinuation, blood eosinophil count at initiation, IgE levels, FeNO levels, and comorbidities.
Asthma control status after discontinuation (e.g., exacerbations, emergency department visits, and changes in inhaler prescriptions).
Utilization of financial support systems, such as the High-Cost Medical Expense Relief Program.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the primary reasons for discontinuing biological agents based on a survey
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 18 years or older at the time of providing informed consent.
Adult asthma patients who have been treated with biologic agents (Xolair, Nucala, Fasenra, Dupixent, or Tezspire).
Patients who have discontinued biologic agents for 3 months or longer and are currently visiting the study institution.
Written informed consent has been obtained from the subject for participation in this study.
Key exclusion criteria
Patients with dementia or psychiatric disorders requiring medical treatment, or patients in a comatose state.
Patients judged by the principal investigator to be unsuitable for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
St. Francis Franciscan Social Medical Corporation, Himeji St. Mary's Hospital
Division name
Department of Respiratory Medicine
Zip code
6700801
Address
650 Nibuno, Himeji, Hyogo, Japan
TEL
0792655111
y0a1s0u7@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakajima |
Organization
St. Francis Franciscan Social Medical Corporation, Himeji St. Mary's Hospital
Division name
Department of Respiratory Medicine
Zip code
6700801
Address
650 Nibuno, Himeji, Hyogo, Japan
TEL
0792655111
Homepage URL
y0a1s0u7@yahoo.co.jp
Sponsor or person
Institute
St. Francis Franciscan Social Medical Corporation, Himeji St. Mary's Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Francis Franciscan Social Medical Corporation, Himeji St. Mary's Hospital
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
St. Francis Franciscan Social Medical Corporation, Himeji St. Mary's Hospital
Address
650 Nibuno, Himeji, Hyogo, Japan
Tel
0792655111
di@himemaria.or.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
| 2026 | Year | 01 | Month | 30 | 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
17
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
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Clinical Timeline & Treatment History
Month/Year of First Visit, Initiation of Biologics, Type of Biologic Agent: Self-injection: [Yes / No], Discontinuation of Biologics, Comorbidities
A. At Initiation of BiologicsFeNO: (ppb), Blood Eosinophil Count (BEC): (/microL), Total IgE: (IU/mL), Maintenance OCS: [Yes (Dose: mg/day) / No], ACT Score: (points), Annual Exacerbation Rate: (times/year)
B. Prior to Discontinuation of BiologicsFeNO: (ppb), Blood Eosinophil Count (BEC): (/microL), Total IgE: (IU/mL), Maintenance OCS: [Yes (Dose: mg/day) / No], ACT Score: (points), Annual Exacerbation Rate: (times/year)
C. Reinitiation & Post-course
Reinitiation of Biologics: [Yes (Type: / Duration: ) / No], ACT Score after Discontinuation: (points)
2. Patient Demographics (Baseline Characteristics)
Age: ( ) years old, Sex: [Male / Female], Occupation: [Full-time employee / Non-regular employee / Self-employed / Unemployed / Pensioner / Unknown], Estimated Annual Household Income:Over approx. 11.6 million JPY, Approx. 7.7 - 11.6 million JPY, Approx. 3.7 - 7.7 million JPY, Under approx. 3.7 million JPY, Low-income household (Exempt from residential tax), Unknown, Family Composition: [Single / Spouse / Children / Living with family / Unknown]
Educational Background: [Junior high school / High school / Junior college or Vocational school / University / Graduate school / Unknown]
3. Discontinuation Details
Main Reason for Discontinuation:Stable symptoms (Clinical remission), Financial reasons, Adverse events (Side effects), Complications of malignant tumors, Pregnancy, Institutionalization, Physician's decision, Patient's preference, Other: ( )
4. Post-discontinuation Course and System Utilization
History of Emergency Visits or Hospitalization after Discontinuation: [Yes / No / Unknown], History of using High-Cost Medical Expense Relief Program: [Yes / No / Unknown], Use of Medical Expense Subsidy Systems (e.g., Self-reliance Support Medical Care): [Yes / No / Unknown]
Management information
Registered date
| 2026 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069244
