A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (TETON-2)
This study, called TETON-2, is testing an inhaled medicine called treprostinil for people who have Idiopathic Pulmonary Fibrosis, or IPF. IPF is a chronic lung disease that causes scarring in the lungs. Researchers want to find out if this new medicine can help improve how well people's lungs work and make them feel better. Some people will receive the new medicine, while others will receive a 'dummy' medicine (placebo) that looks and tastes the same. This allows doctors to compare the effects accurately. The study will last for 52 weeks, and doctors will carefully check lung function and other health measures throughout this time. The aim is to see if treprostinil is both effective and safe for treating IPF.
At a glance
What is this study about?
This research study is focused on Idiopathic Pulmonary Fibrosis (IPF), a serious lung condition where the lungs become scarred and stiff over time, making it harder to breathe. Currently, there isn't a cure for IPF, but doctors are always looking for new treatments to slow its progression and improve quality of life for patients. This particular study is investigating a new inhaled medicine called treprostinil.
The main goal of the study is to see if treprostinil can help improve how well the lungs work in people with IPF. Doctors will measure a specific lung function test called Forced Vital Capacity (FVC), which shows how much air a person can exhale forcefully after taking a deep breath. They want to see if this measurement changes positively after 52 weeks for those taking treprostinil, compared to those taking a dummy medicine. This study is considered a 'Phase 3' study, which means it's a large-scale investigation to confirm the medicine's effectiveness and safety before it can be potentially approved for wider use.
Beyond just lung function, the study will also look at several other important aspects of health over the 52 weeks. This includes how long it takes for a person's condition to get worse, how often they might need to go to the hospital because of their breathing, and how long people live during the study. They will also look at changes in quality of life using a special questionnaire and another lung test called diffusion capacity. By looking at all these factors, researchers hope to get a comprehensive understanding of whether treprostinil can be a helpful new treatment option for people living with IPF.
Key takeaways
- This study is testing an inhaled medicine, treprostinil, for Idiopathic Pulmonary Fibrosis (IPF).
- It aims to see if the medicine improves lung function and overall health over 52 weeks.
- Participants will receive either the active medicine or a dummy medicine (placebo).
- It's a large-scale study (Phase 3) to confirm safety and effectiveness.
- Regular clinic visits, lung tests, and health assessments will be part of participation.
- You can withdraw from the study at any time without affecting your medical care.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. The study is open to both men and women.
There will be other, more detailed criteria to make sure the study includes people who are similar enough for reliable results and to ensure your safety. These might include specific diagnostic tests to confirm your IPF, certain stages of the disease, and whether you are taking other particular medicines.
Before you can take part, doctors will perform various checks and tests to make sure the study is right for you and that you meet all the necessary requirements.
- Are you 18 years old or older?
- Have you been diagnosed with Idiopathic Pulmonary Fibrosis (IPF)?
- Are you able to attend regular clinic visits?
- Are you willing to use an inhaled medicine via a nebuliser?
- Are you able to complete lung function tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you would be randomly assigned to receive either the new medicine (treprostinil) or a dummy medicine (placebo) through a nebuliser. A nebuliser is a device that turns liquid medicine into a fine mist for you to inhale.
The study will last for about 52 weeks (roughly one year). During this time, you would have regular visits to the clinic. These visits would involve various assessments, including lung function tests (like the FVC test), blood tests, and questionnaires about your health and how you're feeling. You would be expected to use the nebuliser solution as instructed. After the main 52-week period, there might be some follow-up appointments to check on your long-term health. The exact number of visits and tests will be explained in detail by the study team.
Potential risks and benefits
Locations (7)
- —Belgium
- —Germany
- —Denmark
- —Italy
- —France
- —Netherlands
- —Spain
Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a chronic lung disease where scar tissue builds up in your lungs, making them stiff and harder to breathe over time. The cause is unknown, which is why it's called 'idiopathic'.
What is treprostinil?
Treprostinil is a medicine that is being tested in this study. It's given as an inhaled solution using a nebuliser, and researchers want to see if it can help improve lung function in people with IPF.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks, feels, and is given just like the real medicine, but it does not contain the active drug. It helps researchers compare the effects of the actual medicine accurately.
How long will the study last?
The main part of the study will last for 52 weeks, which is about one year. There might be some follow-up visits after this time.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps ensure unbiased results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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