UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053589 |
|---|---|
| Receipt number | R000061153 |
| Scientific Title | Validation of an intervention using a novel asthma treatment control index for patients with bronchial asthma |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2025/02/10 18:57:26 |
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Basic information
Public title
Validation of new indicators related to treatment decisions for bronchial asthma
Acronym
Validation of new indicators in the treatment of bronchial asthma
Scientific Title
Validation of an intervention using a novel asthma treatment control index for patients with bronchial asthma
Scientific Title:Acronym
Validation of a new index in the treatment of bronchial asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In general practice, we will examine whether simultaneous evaluation of the ACT and the nasal obstruction severity scores in patients with bronchial asthma contributes to treatment and symptom control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the association between questionnaire scores (combination of the ACT and the nasal obstruction severity score) and treatment choice (presence or absence of treatment changes).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients on regular hospital visits for bronchial asthma
Key exclusion criteria
Consultation outside of an appointment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yumoto |
Organization
Yokohama Minami Kyosai Hospital
Division name
Respiratory Medicine
Zip code
2360037
Address
1-21-1,mutsuurahigashi,Kanazawaku,Yokohama,Kanagawa
TEL
045-782-2101
k-yumoto@minamikyousai.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Yumoto |
Organization
Yokohama Minami Kyosai Hospital
Division name
Respiratory Medicine
Zip code
2360037
Address
1-21-1,mutsuurahigashi,Kanazawaku,Yokohama,Kanagawa
TEL
045-782-2101
Homepage URL
k-yumoto@minamikyousai.jp
Sponsor or person
Institute
Yokohama Minami Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyosai Igakukai
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
Yokohama Minami Kyosai Hospital Clinical Research Review Committee
Address
1-21-1,mutsuurahigashi,Kanazawaku,Yokohama,Kanagawa
Tel
045-782-2101
k-yumoto@minamikyousai.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1_23_7_30
Org. issuing International ID_1
Yokohama Minami Kyosai Hospital Clinical Research Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜南共済病院（神奈川県）、横浜栄共済病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Uncontrolled, open-label, non-interventional observational study
Information to be collected: questionnaire (age, gender, family history, comorbidities (rhinitis, sinusitis, COPD, obesity, depression, anxiety disorders), presence of infections, smoking history, weather conditions for 1 week prior to visit, accuracy of inhalation technique, medication adherence, alcohol consumption history, history of severe asthma exacerbations requiring intubation and ventilatory management, history of severe asthma exacerbations requiring tracheal intubation and ventilator management, and medication use (including medication for comorbidities). (including medications for complications), biomarker testing (blood test findings (white blood cell count, eosinophil count, CRP, total IgE level), exhaled nitric oxide concentration measurement (exhaled NO measurement), respiratory function test), and a questionnaire.
Management information
Registered date
| 2024 | Year | 02 | Month | 09 | 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=R000061153
