Introducing the P1-COPD-04-INT Study for Tobacco Smokers

*Archived*
Study No Longer Active

Study for Tobacco Smokers with
Chronic Obstructive Pulmonary Disease

Designed for people with Mild to Moderate COPD.

About the COPD

The P1-COPD-04-INT study is evaluating how switching to a product called the Tobacco Heating System (THS) may impact symptoms and the disease progression of early chronic obstructive pulmonary disease (COPD) in smokers.

You may be able to join the P1-COPD-04-INT study if you:

  • Are between 35 and 65 years of age
  • Have been smoking for at least 10 years
  • Have been smoking a minimum of 10 cigarettes a day for at least the last year
  • Have not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past year
  • Are not pregnant, if you are female
  • Have experienced cough and sputum (symptoms of chronic bronchitis) over the past year OR have been diagnosed with mild-to-moderate COP

Other criteria will be checked at the first visit and will need to be met to confirm your eligibility for this study.

Why Take Part?

Possible benefits from taking part in this study may include:

  • Close monitoring of health through repeated, detailed check-ups and medical supervision and care.
  • Behavioral support if you chose to stop smoking or to switch to THS.
  • THS and sticks, if you decide to enroll into this group.
  • Smoking cessation advice (provided to all study subjects)Behavioral support if you chose to stop smoking or switch to THS.
  • Nicotine replacement therapy if you decide to stop smoking and would like to be provided with such therapy.
  • Receive compensation up to $900 for inconvenience and travel.

Complete The Questionnaire Below To Submit Your Information For Future Studies

Study Overview

Tobacco Heating System (THS)

THS consists of a rechargeable holder and Tobacco Induction Sticks (Sticks). The Sticks are heated by the holder to generate an aerosol and do not burn, or combust, like cigarettes during use.

If you qualify, you may receive at no cost:

  • THS and sticks, if you decide to enroll into this group.
  • Close monitoring of your health through repeated, detailed check-ups, and medical supervision and care.
  • Smoking cessation advice (provided to all study subjects)Behavioral support if you chose to stop smoking or switch to THS.
  • Nicotine replacement therapy if you decide to stop smoking and would like to be provided with such therapy.
  • Receive compensation up to $750 for inconvenience and travel.

About Clinical Studies

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.

  • Clinical studies follow specific rules and regulations to protect the rights, safety, well-being, and confidentiality of study participants. Clinical studies must be approved by an independent ethics committee before it can begin.
  • The results help competent regulatory authorities to decide if a drug is safe and/or efficacious

Your participation in the P1-COPD-04-INT clinical research study is completely voluntary and can be stopped at any time and for any reason. If you decide not to participate, it will not affect your medical care now or in the future.