Active not recruitingNAINTERVENTIONAL

Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS

This study is for people with a lung condition called COPD and chronic bronchitis who currently smoke cigarettes. Researchers want to compare what happens when these individuals either switch to using a heated tobacco product (THS) or continue smoking traditional cigarettes. The main goal is to see if switching to THS can bring real benefits, like reducing coughs, making breathing easier, and potentially improving how well their lungs work. It will also look at physical abilities, such as how far someone can walk without having to stop. The study is particularly interested in understanding if people feel better and if there are measurable improvements in their health.

At a glance

Status

Active not recruiting

Phase

Sponsor

Philip Morris Products S.A.

Enrolment target

290

Start

02 Apr 2025

Estimated completion

01 Nov 2026

COPD Smoking Tobacco Use

What is this study about?

This study is designed to help us understand the effects of switching from traditional cigarettes to a different type of product called a heated tobacco system (THS). We know that smoking is harmful, especially for people who already have lung conditions like COPD (Chronic Obstructive Pulmonary Disease) and chronic bronchitis. These conditions can cause ongoing coughs, phlegm, and shortness of breath, making everyday activities difficult.

The researchers want to see if switching to a heated tobacco system might help improve some of these symptoms and how people feel overall. They'll be looking carefully at things like how often someone coughs, how easily they can breathe, and how well their lungs are working. They'll also measure physical abilities, such as how far someone can walk in a set amount of time, to get a full picture of any changes.

By comparing people who switch to THS with those who continue smoking cigarettes, the study hopes to find out if using heated tobacco products offers any noticeable benefits for people with COPD. It's important for the researchers to collect this information to better understand different behaviours and their impact on health.

Key takeaways

This study is for smokers with COPD and chronic bronchitis.
It compares switching to heated tobacco products (THS) versus continuing cigarettes.
Researchers will check for improvements in cough, breathing, and lung function.
Participation involves health checks and potentially changing your smoking product.
You can withdraw from the study at any time.
It aims to understand the real-world effects of switching tobacco products.

Who may be eligible?

This study is looking for adults aged 40 or older, both men and women, who have been diagnosed with a lung condition called COPD and chronic bronchitis. To qualify, you must currently smoke at least 10 regular cigarettes a day and have been smoking for at least 10 years. You also need to have been advised to quit smoking and know about stopping programmes, but you shouldn't be planning to quit smoking during the study itself. Your body weight and overall health will also be checked to make sure it's safe for you to take part.

There are also some specific medical requirements related to your COPD. For example, your lung function will be measured to confirm the severity of your condition, and you need to have a consistent cough and mucus production. You'll also need to be willing to potentially be assigned to either switch to heated tobacco products or continue with your current cigarettes.

You wouldn't be able to join this study if you've recently used other nicotine products (besides cigarettes) or cannabis, or if your COPD has recently gotten much worse.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 40 years old or older?
Do you have COPD and chronic bronchitis?
Do you currently smoke at least 10 cigarettes a day and have smoked for over 10 years?
Are you able to attend regular health check-ups and tests?
Are you not currently planning to quit smoking during the study?
Have you not used other nicotine products (besides cigarettes) or cannabis in the last year?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have a few visits where doctors will check your health, confirm your lung condition, and make sure you fit all the requirements. You'll also need to read and sign a form that explains everything about the study in detail.

Once accepted, you'll be randomly put into one of two groups: one group will switch from regular cigarettes to the heated tobacco system (THS), and the other group will continue smoking their usual cigarettes. You won't get to choose which group you're in. Over the course of the study, you'll have regular check-ups and tests. These will involve things like lung function tests (to see how well your lungs are working), measuring your cough, and a walking test to see how far you can walk. The exact duration of the study isn't specified here, but clinical studies usually involve several follow-up visits over a period of weeks or months to track changes.

Potential risks and benefits

Participating in ANY research study has both potential benefits and potential risks. You might benefit from closer monitoring of your health and lung condition than usual. If you are in the group that switches to heated tobacco products, there's a chance your symptoms like cough and breathlessness could improve, and your lung function might become better. However, it's also important to remember that using heated tobacco products is not risk-free and their long-term health effects are still being studied. For those continuing to smoke cigarettes, the risks associated with smoking remain. You will be told about all known risks before you agree to take part, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (112)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Clinical Research of West Florida, Inc.
Verified postcode
Clearwater, United States
Florida International Medical Research
Verified postcode
Coral Gables, United States
Alfa Medical Research
Verified postcode
Davie, United States
Omega Research Debary, LLC
Verified postcode
DeBary, United States
D&H Doral Research Center
Verified postcode
Doral, United States
Felicidad Med Research
Verified postcode
Hialeah, United States
New Life Medical Research Center, Inc
Verified postcode
Hialeah, United States
The Medici Medical Research, LLC
Verified postcode
Hollywood, United States
D&H Pompano Research Center
Verified postcode
Margate, United States
Med-Care Research Corp
Verified postcode
Miami, United States
EMDA Clincal Research
Verified postcode
Miami, United States
Sones Medical Research
Verified postcode
Miami, United States

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a lung condition that makes it hard to breathe, often causing a long-term cough and shortness of breath.

What are Heated Tobacco Systems (THS)?

Heated Tobacco Systems (THS) are products that heat tobacco to create a nicotine-containing vapour, rather than burning it like traditional cigarettes. They are different from e-cigarettes.

Will I have to stop smoking or using THS during the study?

No, if you join the study, you'll either continue smoking cigarettes or switch to using heated tobacco products for the duration of the study. You won't be asked to stop using nicotine products entirely while you're participating.

What does 'randomized study' mean?

'Randomized' means that you'll be put into one of the study groups by chance, like flipping a coin. This helps make sure the study results are fair and unbiased.

What is a 'six-minute walking test'?

This is a simple test where you walk as far as you can in six minutes, usually along a marked corridor. It helps doctors understand your fitness and how well your lungs support physical activity.