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This study is looking for former smokers who are between 40 and 85 years old with chronic obstructive pulmonary disease (COPD).
Sanofi believes that everyone should have the opportunity to take part in clinical trials. It is important to include people who have been historically underrepresented in clinical trials. Sanofi is committed to inclusivity in our studies
If you are interested in learning more about this study, we encourage you to complete a short questionnaire to help determine if you may qualify to participate and be referred to a site recruiting in your area for further evaluation.
Treatments for COPD may still leave you looking for relief from wheezing, coughing, and shortness of breath.
That's why Sanofi is researching if an investigational medicine plus certain controller therapies could potentially:
- Lessen COPD symptoms
- Improve breathing and overall well-being
Study Information
How long is the study?
- About 1½ years
How many study visits are there?
- About 16 clinic visits lasting a few hours each
- About 16 phone calls (or clinic visits, depending on the participant)
What happens at study visits?
- Spirometry tests
- Blood draws
- Urine samples
- Vital sign checks
- Electronic diary (eDiary) review
FAQ
What are clinical research studies?
Clinical research studies (also called clinical trials) are used to show if/how an investigational medicine works and if it is safe.
Clinical studies are run by healthcare professionals. Doctors and other healthcare providers are responsible for study-related care for the people who participate (or enroll) in studies. Clinical studies are a mandatory part of the process that can lead to a medicine being approved for the general public to use.
Institutional review boards (IRBs) are independent committees made up of medical and nonmedical people who also watch over clinical studies to make sure people who enroll are properly and adequately informed and consent prior to study participation.
What is an investigational medicine?
An investigational medicine is what is being studied to learn more about its safety and efficacy. This potential treatment has not been approved for use for the general public.
How is the investigational medicine given in this
clinical research study?
The investigational medicine is given as an injection (through a needle) under the skin.
In this study, you will be randomly placed into a potential treatment group to receive the:
- Investigational medicine + your controller therapies
- Placebo + your controller therapies
A placebo is given in the same way as the investigational medicine, but it doesn’t contain any active ingredients.
How many people are in this clinical research
study?
This study will enroll approximately 930 former smokers worldwide.
What are the risks and benefits of taking part?
As with any clinical study, there are risks and benefits of taking part. Your health may get better, get worse, or stay the same. You will have access to specialized medical professionals and could help researchers learn more about treating COPD.
Is there a cost to participate?
No. All study-related care is provided at no cost, including exams, medicines, and other related medical care.
You may receive a stipend. The study team will discuss this with you before you decide to take part.
Am I eligible?
Can I participate?
Complete this brief questionnaire (# questions, length of time) to help determine if you may qualify to be referred to a site recruiting in your area for further evaluation for potential participation in this clinical study.
You can also add your contact information to be notified of future Sanofi studies.
You can also add your contact information to be notified of future Sanofi studies.
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