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A 3-year, 3-group, Preference, Multi-center Study to Demonstrate the Slowing of Disease Progression When Switching From Cigarette Smoking to the Tobacco Heating System (THS) in Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) Subjects With a History of Chronic Bronchitis Symptoms.

Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.

Furihata Kenichi

Keikokai Medical Corp P-one Clinic

View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo

Japan-Chiken@iconplc.com

Clinical trial contact

ICON Clinical Research GK

4-1-3 Kyutaro-cho, Chuuou-ku, Osaka-city, Osaka, 541-0056, Japan

+81-6-4560-2001

Japan-Chiken@iconplc.com

Suspended

May. 20, 2023

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

other

1. Subjects have read, understood, and signed the written informed consent form (ICF)
2. Diagnosis of COPD GOLD Stage 1 or 2 (FEV1/FVC <0.7 and FEV1 >=60% predicted [post-BD])
3. History of chronic bronchitis symptoms (sputum and cough) over the previous 12 months assessed by CAT1 and CAT2 scores >= 3
4. Body mass index (BMI) 17.6-40.0 kg/m2 and body weight > 50 kg (male) or 40 kg (female).
5. Subject has a smoking history of at least 10 years.
6. Subject has been smoking >= 10 commercially available cigarettes/day on average (no brand restriction) for at least 1 year prior to V1 (based on self-reporting).
7. Subject has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past year prior to V1.
8. For subjects not willing to quit smoking only: have been advised to quit smoking, informed of smoking risks and of cessation programs and is still not willing to quit during the study duration.
9. Subjects willing to quit smoking only: willing to set a target quit date (TQD) within the next 28 days at V1 as assessed by self-reported questions.

1. Subjects with any (mild, moderate or severe) COPD exacerbation that has not resolved at least four weeks prior to V1
2. Subjects with other relevant pulmonary diseases than COPD. No new examination is required if the subject can present at V1, a Chest X-Ray (CXR) not older than 6 months with anterior-posterior and left lateral views
3. Subjects with pneumonia or other lower respiratory tract infections that have not resolved at least four weeks prior to V1
4. Subjects with other active systemic infections that have not resolved at least 4 weeks prior to V1
5. Subjects with other active respiratory disorders: tuberculosis, lung cancer, bronchiectasis, sarcoidosis, asthma, pulmonary hypertension, interstitial lung diseases (e.g., idiopathic pulmonary fibrosis [IPF]), or other active pulmonary diseases during the screening period (V1 to V2)
6. The subject is confirmed or suspected with active SARS-CoV-2 infection (as per site and per country recommendation)
7. Clinically significant ECG alterations that will not allow subject to participate in the study, per Investigator's discretion
8. Any concomitant disease that in the opinion of the investigator would interfere with the study procedures
9. Subjects with diagnosed alpha-1 antitrypsin deficiency (AATD)
10. History of alcohol and / or drug abuse (other than tetrahydrocannabinol [THC]).
11. Positive serology test (HIV 1/2, hepatitis B or C).
12. Inability to cooperate with the study procedures
13. Previous participation in this study, or participation in an investigational study (drug or medical device) within 4 weeks before V1 (participation in observational studies/registries allowed)
14. Close affiliation with the investigational site: a close relative of the investigator, a person dependent on the investigational site (e.g., employee or student of the investigational site)
15. Subject is a current or former employee of the tobacco industry or their first-degree relatives (parent, child, spouse)
16. Subjects have re-initiated smoking in the six months prior to V1
17. Subjects have used in the past 3 months, or are currently daily using THS
18. Any oral or injectable corticosteroids (acute or chronic treatments) in the 2 months preceding V1, excluding short term use for a COPD exacerbation.
19. Female subject is pregnant or breastfeeding, (a urine pregnancy test will be performed at V1 and V2)
20. For women of childbearing potential, female subject who does not agree to using an acceptable method of effective contraception during the entire study.

Both

COPD, Smoking, Tobacco Use

- THS use
Subjects who are not willing to quit smoking during the study duration will switch from cigarettes to using THS
Other Name: Tobacco Heating System 3.0
- Cigarette
Subjects who are not willing to quit smoking during the study duration will continue smoking their own preferred brand of commercially available cigarettes.
- Smoking Abstinence
Subjects who are willing to quit smoking may be prescribed an NRT to support them in remaining abstinent from use of any tobacco and nicotine containing products during the study. (Behavioral support will be provided to subjects to aid with abstinence.)

- Symptoms: COPD Assessment Test (CAT) total score at Month 12 for the interim analysis
- Disease progression: Forced Expiratory Volume in 1 second (FEV1), post-bronchodilator (-BD) at Month 36

+81-42-625-5216

Jan. 17, 2023

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