Male/female adults
Conditions
Interventions
None listed
Sponsors
Chiyoda Paramedical Care Clinic
Micron, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the agreement of FEV1 measurements obtained from a spirometer and the smartphone application in users of heated tobacco products. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed