UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058333 |
|---|---|
| Receipt number | R000066689 |
| Scientific Title | Stepping Down LAMA from Triple Therapy in Adult Asthma Patients |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/07/01 15:20:23 |
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Basic information
Public title
Stepping Down LAMA from Triple Therapy in Adult Asthma Patients
Acronym
Stepping Down LAMA from Triple Therapy in Adult Asthma Patients
Scientific Title
Stepping Down LAMA from Triple Therapy in Adult Asthma Patients
Scientific Title:Acronym
Stepping Down LAMA from Triple Therapy in Adult Asthma Patients
Region
| Japan |
Condition
Condition
adult asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety of discontinuing LAMA while continuing ICS/LABA in patients with stable asthma who have been receiving triple therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of asthma exacerbations
Key secondary outcomes
Median time to asthma exacerbation
Change from baseline in FEV1 and FEV1 predicted
Change from baseline in ACT score
Change from baseline in FeNO
Change from baseline in blood eosinophil count
Univariate analysis of baseline characteristics between patients with and without asthma exacerbation
Univariate analysis of the association between asthma exacerbation and checklist items related to airway hyperresponsiveness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
withdrawing LAMA from ICS/LABA/LAMA therapy
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 attending the outpatient internal medicine clinic of Yamanashi Red Cross Hospital between August 1, 2025, and July 31, 2026, will be screened. Eligible patients are those aged 18 years or older who have been diagnosed with asthma according to the 2024 Asthma Prevention and Management Guidelines, and who meet all of the following criteria within 28 days prior to Visit 1, with the ability to provide written informed consent:
1 Have been receiving ICS/LABA/LAMA therapy for at least 6 months
2 Have an Asthma Control Test (ACT) score >2
3 Have had no asthma exacerbation in the past year (regardless of severity), defined as any of the following: treatment with oral or systemic corticosteroids, emergency department visits, or hospitalization
4 Have had no use of oral corticosteroids as maintenance therapy within the past year
Key exclusion criteria
1 asthma COPD overlap diagnosed according to the Guidelines for the Diagnosis and Treatment of Asthma COPD Overlap 2nd edition
2 Cough variant asthma
3 Unable to provide written informed consent
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Fukuda |
Organization
Yamanashi Red Cross Hospital
Division name
Department of Medicine, Division of Respiratory Medicine
Zip code
401-0301
Address
6663-1 Funatsu, Fujikawaguchiko-machi, Yamanashi, Japan
TEL
+81-555-72-2222
yosukefukuda.showa@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Fukuda |
Organization
Yamanshi Red Cross Hospital
Division name
Department of Medicine, Division of Respiratory Medicine
Zip code
401-0301
Address
6663-1 Funatsu, Fujikawaguchiko-machi, Yamanashi, Japan
TEL
+81-555-72-2222
Homepage URL
yosukefukuda.showa@gmail.com
Sponsor or person
Institute
Yamanashi Red Cross Hospital
Institute
Department
Personal name
Yosuke Fukuda
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamanashi Red Cross Hospital Ethics Committee
Address
6663-1 Funatsu, Fujikawaguchiko-machi, Yamanashi
Tel
+81-555-72-2222
yosukefukuda.showa@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
--- Select One ---
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066689
