UMIN-ICDS Clinical Trial

Public title

A Study on Pulmonary Function Using a Smartphone Application

Acronym

A Study on Pulmonary Function Using a Smartphone Application

Scientific Title

A Study on Pulmonary Function Using a Smartphone Application

Scientific Title:Acronym

A Study on Pulmonary Function Using a Smartphone Application

Region

Japan

Condition

Male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the reliability and practicality of pulmonary function measurement using a smartphone application by comparing FEV1 values obtained from the application with those measured by a conventional spirometer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To evaluate the agreement of FEV1 measurements obtained from a spirometer and the smartphone application in users of heated tobacco products.

Key secondary outcomes

To evaluate the rate of change in FEV1 after 12 months of observation in users of heated tobacco products.
To explore the relationship between the timing of switching to heated tobacco products and the 12-month change rate in FEV1.
To evaluate the agreement of FEV1 measurements obtained from a spirometer and a smartphone application in users of conventional combustible cigarettes.
To evaluate the rate of change in inflammatory biomarkers after 12 months of observation.
To evaluate the 12-month change rates in pulmonary function parameters (respiratory rate [RR], tidal volume [TV], peak expiratory flow [PEF], forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC], and FEV1/FVC ratio) measured by both the spirometer and the smartphone application, and to assess changes in questionnaire scores (CAT and SGRQ).
To evaluate the agreement of change rates in pulmonary function parameters (RR, TV, PEF, FEV1, FVC, and FEV1/FVC ratio) measured by the spirometer and the smartphone application before observation and at 6 and 12 months after observation.
Incidence of chronic obstructive pulmonary disease (COPD) during the observation period.
Longitudinal changes in pulmonary function parameters measured by the smartphone application at home.
Adherence status regarding the use of the smartphone application.
Occurrence of adverse events.
Occurrence of malfunctions or technical issues related to the smartphone application.

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

30

years-old

<=

Age-upper limit

61

years-old

>

Gender

Male and Female

Key inclusion criteria

Subjects using heated tobacco products
1. Japanese males or females aged 30 years or older and under 61 years at the time of informed consent.
2. Individuals who have smoked the equivalent of 10 or more packs per year for at least 10 consecutive years and are currently smoking heated tobacco products, and who have a history of smoking conventional combustible cigarettes for 5 years or more.
The total smoking duration may include both heated and conventional cigarettes.
3. Individuals who continue to use heated tobacco products at the time of the pre-observation examination.
4. Individuals who are able to participate in a one-year observational study.
5. Individuals who own a smartphone with a camera, operating on Android 10 or later, or iOS 16 or later.
6. Individuals who can access the designated application and are able to participate from home once a month.
7. Individuals who have received a full explanation of the study, understand the content, and voluntarily provide written informed consent.

Subjects using conventional combustible cigarettes
1. Japanese males or females aged 30 years or older and under 61 years at the time of informed consent.
2. Individuals who have smoked conventional combustible cigarettes for at least 10 consecutive years, consuming 10 or more packs per year during that period.
3. Individuals who continue to smoke conventional cigarettes at the time of the pre-observation examination.
4. Individuals who are able to participate in a one-year observational study.
5. Individuals who own a smartphone with a camera, operating on Android 10 or later, or iOS 16 or later.
6. Individuals who can access the designated application and are able to participate from home once a month.
7. Individuals who have received a full explanation of the study, understand the content, and voluntarily provide written informed consent.

Key exclusion criteria

1. Individuals who are currently using any of the following medications:
beta-blockers, systemic or inhaled corticosteroids, anticholinergic drugs, beta2-agonists (bronchoconstrictors or bronchodilators), theophylline preparations, or leukotriene receptor antagonists.
2. Individuals who have been diagnosed with respiratory diseases such as asthma or chronic obstructive pulmonary disease (COPD).
3. Individuals with any of the following medical histories or comorbidities, regardless of the time of onset:
History of thoracic or abdominal surgery
Myocardial infarction or angina pectoris
Uncontrolled hypertension (Grade III or higher)
4. Individuals who have attempted smoking cessation within 28 days prior to obtaining informed consent.
5. Females who are pregnant, breastfeeding, or intending to become pregnant during trial period.
6. Individuals who donated 200 mL of their blood or blood components within the last month.
7. Individuals who donated 400 mL of his blood within the last 3 months.
8. Individuals who donated 400 mL of her blood within the last 4 months.
9. Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
10. Individuals who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
11. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
12. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Target sample size

150

Name of lead principal investigator

1st name	Shukuko
Middle name
Last name	Ebihara

Organization

Chiyoda Paramedical Care Clinic

Division name

Clinic Director

Zip code

103-0021

Address

2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9005

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Makoto
Middle name
Last name	Ichinohe

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

Chiyoda Paramedical Care Clinic

Institute

Department

Personal name

Organization

electronRx Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Micron, Inc.

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan

Tel

03-6225-9005

Email

IRB@cpcc.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

11

Month

20

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

Preinitiation

Date of protocol fixation

2025

Year

11

Month

11

Day

Date of IRB

2025

Year

11

Month

07

Day

Anticipated trial start date

2025

Year

11

Month

21

Day

Last follow-up date

2027

Year

01

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The target sample size is 150 participants, consisting of 120 subjects who use heated tobacco products and 30 subjects who use conventional combustible cigarettes.

Registered date

2025

Year

11

Month

20

Day

Last modified on

2025

Year

11

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067800