Tokyo, Nov. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059834) titled 'A Study on Pulmonary Function Using a Smartphone Application' on Nov. 20.
Study Type:
Observational
Primary Sponsor:
Institute - Chiyoda Paramedical Care Clinic
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 30
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 Size - 150
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067800
Disclaimer: Curated by HT Syndication.
