UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061809 |
|---|---|
| Receipt number | R000070018 |
| Scientific Title | SWITCH-26 Study: A Longitudinal Questionnaire Study on the Impact of Switching to a 26-Week Injectable Therapy on Convenience and Psychological Burden in Patients with Bronchial Asthma |
| Date of disclosure of the study information | 2026/06/05 |
| Last modified on | 2026/06/05 15:13:37 |
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Basic information
Public title
SWITCH-26 Study: A Longitudinal Questionnaire Study on the Impact of Switching to a 26-Week Injectable Therapy on Convenience and Psychological Burden in Patients with Bronchial Asthma
Acronym
SWITCH-26 Study
Scientific Title
SWITCH-26 Study: A Longitudinal Questionnaire Study on the Impact of Switching to a 26-Week Injectable Therapy on Convenience and Psychological Burden in Patients with Bronchial Asthma
Scientific Title:Acronym
SWITCH-26 Study
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to longitudinally evaluate changes in convenience and psychological burden in patients with bronchial asthma who switch from conventional biologic therapies to a long-acting injectable therapy administered every 26 weeks. In addition, this study aims to assess temporal changes in patient-reported outcomes, including treatment satisfaction, and to examine the impact of extended dosing intervals on patient-centered outcomes.
Basic objectives2
Others
Basic objectives -Others
As secondary objectives, this study will exploratorily evaluate the impact of switching to a long-acting injectable therapy on clinical outcomes in asthma. Specifically, changes in asthma control (including clinical remission), exacerbation frequency, ACT scores, lung function (FEV1), and peripheral blood eosinophil counts over time will be assessed.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in treatment satisfaction score from baseline (prior to switching) to 6 months after switching to a long-acting injectable therapy, assessed using a questionnaire.
Key secondary outcomes
Change in convenience score (baseline, 6 months, and 12 months; questionnaire using a 5-point Likert scale)
Change in psychological burden score (baseline, 6 months, and 12 months; questionnaire using a 5-point Likert scale)
Change in treatment satisfaction score (baseline, 6 months, and 12 months; questionnaire using a 5-point Likert scale)
Change in the proportion of patients achieving clinical remission (baseline and 12 months)
Change in the number of asthma exacerbations (comparison between 12 months before and 12 months after switching)
Change in Asthma Control Test (ACT) score (baseline, 6 months, and 12 months)
Change in lung function (FEV1) (baseline, 6 months, and 12 months)
Change in peripheral blood eosinophil count (baseline, 6 months, and 12 months)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older at the time of consent
Patients who have been receiving the same biologic therapy (omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab) for at least 12 months at the time of consent
Patients who switch to a long-acting injectable therapy administered every 26 weeks
Patients who provide written informed consent after receiving sufficient explanation of the study
Key exclusion criteria
Patients who changed biologic therapy within 12 months prior to consent
Patients who received unapproved biologic therapies within 12 months prior to consent
Patients who received pharmacological treatment for malignancy within 12 months prior to consent
Patients deemed inappropriate for participation by the investigator
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Miyazaki |
Organization
University of Miyazaki
Division name
Division of Respirology, Rheumatology, Infectious Diseases, and Neurology, Department of Internal Medicine, Faculty of Medicine
Zip code
889-1608
Address
Kihara 5200, Kiyotake, Miyazaki
TEL
0985857284
taiga_miyazaki@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Tsubouchi |
Organization
University of Miyazaki
Division name
Division of Respirology, Rheumatology, Infectious Diseases, and Neurology, Department of Internal Me
Zip code
889-1608
Address
Kihara 5200, Kiyotake, Miyazaki
TEL
0985852965
Homepage URL
hironobu_tsubouchi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
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
University of Miyazaki Hospital Clinical Research Support Center
Address
Kihara 5200, Kiyotake, Miyazaki
Tel
0985859403
rinken@med.miyazaki-u.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
| 2026 | Year | 06 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 06 | 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
| 2026 | Year | 06 | Month | 05 | Day |
Last modified on
| 2026 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070018
