UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054006 |
|---|---|
| Receipt number | R000061647 |
| Scientific Title | A prospective study comparing airway lesions in patients with asthma and cough-variant asthma using impulse oscillometry (IOS) examination results based on the MOST graph conducted on patients diagnosed with asthma and cough-variant asthma after November 2020. |
| Date of disclosure of the study information | 2024/03/29 |
| Last modified on | 2025/09/29 09:15:07 |
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Basic information
Public title
A prospective study comparing airway lesions in patients with asthma and cough-variant asthma using impulse oscillometry (IOS) examination results based on the MOST graph conducted on patients diagnosed with asthma and cough-variant asthma after November 2020.
Acronym
A prospective study comparing airway lesions in patients with asthma and cough-variant asthma using impulse oscillometry (IOS) examination results based on the MOST graph conducted on patients diagnosed with asthma and cough-variant asthma after November 2020.
Scientific Title
A prospective study comparing airway lesions in patients with asthma and cough-variant asthma using impulse oscillometry (IOS) examination results based on the MOST graph conducted on patients diagnosed with asthma and cough-variant asthma after November 2020.
Scientific Title:Acronym
A prospective study comparing airway lesions in patients with asthma and cough-variant asthma using impulse oscillometry (IOS) examination results based on the MOST graph conducted on patients diagnosed with asthma and cough-variant asthma after November 2020.
Region
| Japan |
Condition
Condition
Asthma and Clinical Cough-Variant Asthma
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively compare impulse oscillometry (IOS) results using MOST graph in patients registered since ethical approval from November 2020 onwards at our facility, diagnosed with asthma and those considered to have cough-variant asthma with a potential to transition to asthma.
Basic objectives2
Others
Basic objectives -Others
To prospectively compare various examination results and impulse oscillometry (IOS) results using MOST graph in patients diagnosed with asthma who have been enrolled since ethical approval from November 2020 onwards at our facility, and patients diagnosed with cough-variant asthma, which is considered a prodromal state of asthma with potential transition to asthma.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A comparison of Impedance Oscillation system utilizing MOST graph at the time of diagnosis between asthma patients enrolled since ethical approval from November 2020 at our facility and patients diagnosed with clinical cough-variant asthma
Key secondary outcomes
To compare various examination results and Impulse Oscillometry (IOS) results using MOST graph between asthma patients enrolled since ethical approval from November 2020 at our facility and patients diagnosed with cough-variant asthma, which is considered a prodromal state of asthma with potential transition to asthma.
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
| Maneuver |
Interventions/Control_1
Measure airway resistance using MostGraph in patients diagnosed with asthma or cough variant asthma, in conjunction with diagnostic tests.
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
From November 2020 to March 2024, patients diagnosed with clinical cough-variant asthma and asthma at the Japan Medical University Hospital Respiratory Medicine Department and Japan Medical University Respiratory Care Clinic were prospectively enrolled and their data analyzed. This study was devised and executed to investigate the results obtained when performing Impulse Oscillometry (IOS) using the MostGraph in asthma patients, compare these results with those of patients with cough-variant asthma, and assess whether the MostGraph results reflect the airway lesions of asthma patients. The aim was to examine the potential usefulness of the MostGraph in understanding the airway lesions of asthma patients. The selection criteria were as follows:
1 Patients aged 20 years or older (both sexes).
2 Patients diagnosed with asthma or CVA at our facility or those referred from other institutions with a diagnosis of asthma based on reversible airflow tests and clinical history, where exclusion of other diseases was confirmed.
3 Patients with stable symptoms persisting for at least three months, continuing until the completion of the assessments, and not requiring the introduction of new treatments until the initiation of treatment for the disease diagnosed after these assessments.
4 Patients without any severe condition requiring immediate treatment.
5 Patients in whom any disease associated with airflow obstruction requiring medications other than bronchodilators could be ruled out, and who were not taking ACE inhibitors.
6 Patients without diseases that could obscure the diagnosis of asthma or CVA.
7 Patients who have been informed about the study using an informed consent document and have provided consent to participate in this study.
Note: CVA typically stands for cough-variant asthma.
Key exclusion criteria
Exclusion criteria:
1) Patients who have no symptoms, including cough or symptoms derived from asthma.
2) Patients with acute symptoms requiring immediate treatment intervention.
3) Patients with diseases causing cough requiring medication other than bronchodilators, unrelated to asthma or CVA.
4) Patients receiving medication (such as ACE inhibitors) that hinder the definitive diagnosis of asthma or CVA.
5) Patients with conditions that hinder the definitive diagnosis of asthma or CVA.
6) Patients lacking decision-making capacity.
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Niippon Medical School
Division name
Department of Respiratory Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
yosuke-t@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Nippon Medical School
Division name
Department of Respiratory Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
yosuke-t@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Yosuke Tanaka
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
N/A
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
the ethics committees of the Nippon Medical School Hospital
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
03-3822-2131
nms@esct.bvits.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
Institutions
Institutions
日本医科大学付属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare and evaluate the results of Impulse Oscillometry (IOS) using the MOST graph, diagnosed with asthma or cough variant asthma at our facility, alongside other indicators.
Management information
Registered date
| 2024 | Year | 03 | Month | 29 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061647
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/07/05 | BACVA実施計画書(大・付)_1712.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/04/09 | 登録仕様.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/04/09 | UMIN用.jmp |
Single case data URL
Value
https://center6.umin.ac.jp/ice/61647
