New Research Study For Adults With COPD

A research study involving human subjects is designed to answer specific questions about the safety and/or efficacy of an intervention (drug, treatment, device, or other products), or new ways of using a known drug, treatment, device, or product before or during an investigational drug or product is made available to the public.

There are common assessments that are performed during most clinical studies. Here is what you can expect during the P1‑COPD‑04‑INT study:

1. Read and sign the Informed Consent Form (ICF)

• The ICF explains the study in more detail. The study doctor will explain the information in the ICF and answer any questions. 
• You must sign the ICF before receiving any study treatment or assessments. 
• Remember that taking part in the study is your choice. You can stop at any time. 

2. Confirm that you can join the study

Participants who would like to join the study will undergo screening to ensure they are a good fit. Study assessments/procedures may include: 

• Demographics: You will be asked to provide personal information, including date of birth, gender, ethnic origins, and race. 
• Medical History: You will be asked about your past and present health conditions, including COPD. You must provide accurate and complete information about your medical history and present health conditions. 
• Physical Exam: You will have physical examinations and tests, including COVID test, urine samples, lung function (spirometry) tests, and electrocardiogram (ECG), among others.  

3. Choose a study group

Participants who meet the study requirements will choose to be in one of 3 groups, based on personal preference:

• Those who completely switch to the THS product (THS group)
• Those who are not willing to quit smoking nor to switch to the THS product but who will be willing to continue to smoke cigarettes of their choice (Cigarette group)
• Those who decide to stop smoking and using any tobacco and/or nicotine containing products (SA group)

Columbus Office:

•  Address: 5353 Veterans Parkway Suite D, Columbus, GA 31904
• Principan Investigator: Joshua Samraj, M.D.

Carrollton Office: 

• Address: 909 South Park Street, Carrollton, GA 30117
• Principal Investigator: Anthony Olofintuy, M.D.

Participation in the P1-COPD-04-INT study will last about 40 months. It includes:

• Screening: up to 28 days
• Run-in period: 2 weeks (for participants who are not willing to quit smoking)
• Grace period: 2 weeks for subjects who decide to quit smoking and using nicotine/tobacco products
• Study period: 3 years
• Study visits: at 6, 11, 12, 24, 35 and 36 months
• THS supply visits: every month (for participants in the THS group), or as needed
• Safety follow-up: 28 days after the last study visit

No, you do not have to pay to participate in a clinical study.

• It does not cost participants any money to join this clinical study, and they do not need health insurance to join.
• The study-related treatment and study visits will be of no cost to participants or their insurance companies.

Yes. You may decide to stop taking part in the P1-COPD-04-INT study at any time and without providing any reason. If you withdraw from the study before the end of the study period or if you are discontinued by the study Investigator, you will be asked to return to the study site for an early termination visit, within 5 days of your withdrawal or discontinuation.