UMIN-ICDS Clinical Trial

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 clinical 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 clinical 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 clinical cough-variant asthma after November 2020.

Scientific Title:Acronym

Comparison of Airway Lesions in Asthma and Clinical Cough-Variant Asthma Patients Using Impulse Oscillometry (IOS) Examination Results Based on MOST Graph

Region

Japan

Condition

Asthma and Clinical Cough-Variant Asthma

Classification by specialty

Medicine in general

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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 and above (both sexes).
2. Patients diagnosed at our facility with asthma or CVA*, or diagnosed with asthma based on the results of airway reversibility tests or clinical course at other hospitals, and upon referral to our facility, exclusion diagnosis of diseases or conditions different from asthma or cough-variant asthma that can explain symptoms of asthma or cough-variant asthma.
3. Patients with stable symptoms persisting for at least 3 months but not completely disappearing for more than 4 weeks.
4. Patients without any serious diseases requiring immediate treatment.
5. Patients in whom diseases associated with 'airflow disease requiring medication other than bronchodilators' or taking ACE inhibitors could be excluded.
6. Patients without conditions that hinder the definitive diagnosis of asthma or CVA
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

360

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

Email

yosuke-t@nms.ac.jp

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

Email

yosuke-t@nms.ac.jp

Institute

Nippon Medical School

Institute

Department

Personal name

Yosuke Tanaka

Organization

Nippon Medical School

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

N/A

Co-sponsor

None

Name of secondary funder(s)

None

Organization

the ethics committees of the Nippon Medical School Hospital

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan

Tel

03-3822-2131

Email

nms@esct.bvits.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

日本医科大学付属病院(東京都)

Date of disclosure of the study information

2024

Year

03

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public 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 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.

Registered date

2024

Year

03

Month

29

Day

Last modified on

2024

Year

04

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061647