Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease
This study is a long-term follow-up for people with serious lung conditions such as Idiopathic Pulmonary Fibrosis (IPF) or other forms of progressive lung scarring. Participants will continue to use an inhaled medicine called treprostinil, which they've already received in previous related studies. The main goal is to carefully check how safe this medicine is over a longer period and whether it helps improve or manage the lung condition. Researchers will regularly monitor lung function, general health, and any side effects. This important research helps doctors understand if treprostinil can be a safe and effective treatment option for conditions that currently have limited treatments.
At a glance
What is this study about?
This study is a continuation for people who have already taken part in earlier research looking at an inhaled medicine called treprostinil. It's designed for individuals living with specific types of lung scarring, including Idiopathic Pulmonary Fibrosis (IPF) or other forms of progressive pulmonary fibrosis. These conditions cause the lung tissue to become thick and stiff over time, making it hard to breathe.
The main purpose of this follow-up study is to see how safe treprostinil is when used for a longer period, up to six years. Researchers will also be looking to understand if the medicine has any positive effects on the lung condition. Because treatments for these types of lung diseases are very much needed, carefully studying new medicines over time is very important to see if they can help people live better.
Participants will regularly visit the clinic, where doctors and nurses will check their lungs, general health, and monitor for any side effects. This detailed information will help medical experts learn more about treprostinil and whether it could become a widely available treatment in the future. Your ongoing participation helps build a complete picture of this medicine's potential.
Key takeaways
- This is a long-term follow-up study for participants of previous treprostinil trials.
- It aims to assess the safety and long-term effects of inhaled treprostinil for lung scarring conditions.
- Participants will have regular check-ups, breathing tests, and blood tests.
- The study could last up to six years, with close monitoring of your health.
- Your continued participation helps advance understanding of this potential treatment.
Who may be eligible?
To join this study, you must have already taken part in one of the previous treprostinil studies (RIN-PF-301, RIN-PF-303, or RIN-PF-305) and completed it, or were still in one of those studies when it ended for reasons other than your safety. This means you would have already received the study medicine.
Both men and women can join. If you are a woman who could become pregnant, you'll need to confirm you're not pregnant or breastfeeding and agree to use two reliable forms of birth control throughout the study and for 30 days afterwards. If you are a man with a partner who could become pregnant, you'll need to use a condom during the study and for 48 hours after stopping the medicine.
You should also be able to communicate well with the study team and be willing to follow all the study instructions and attend all appointments. The study staff will ensure that taking part would not put your health at risk.
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.
- I have previously participated in study RIN-PF-301, RIN-PF-303, or RIN-PF-305.
- I completed my previous study or was still enrolled when it ended for non-safety reasons.
- I am able to attend regular study appointments and communicate with the team.
- If I am a woman who could become pregnant, I am not pregnant/breastfeeding and will use effective birth control.
What does participation involve?
If you join this study, you'll continue to use the inhaled medicine called treprostinil, which you'll take using a special nebulizer (a device that turns liquid medicine into a fine mist you breathe in). You will have regular check-ups at the study clinic, starting at Week 4, then Week 12, and every 12 weeks after that.
During these visits, the study team will carry out various tests. These include breathing tests to measure your lung function (like how much air you can breathe out), blood tests, checking your heart with an ECG, and seeing how much oxygen you use. You'll also answer questionnaires about your health and how you feel, such as the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire. Your doctor will also check for any side effects you might experience.
The study could last for up to six years, unless the medicine becomes widely available, the study is stopped by the sponsor, or you need to stop due to side effects or another reason. Throughout this time, you will be carefully monitored to ensure your safety and to see how the medicine is affecting your condition.
Potential risks and benefits
Locations (194)
- The University of Alabama at BirminghamVerified postcodeBirmingham, United States
- Clinical Trials Center of Middle TennesseeVerified postcodeFranklin, United States
- Banner University Medical Center-PhoenixVerified postcodePhoenix, United States
- St. Joseph's Hospital and Medical Center - Norton Thoracic InstituteVerified postcodePhoenix, United States
- University of ArizonaVerified postcodeTucson, United States
- UC San Diego HealthVerified postcodeLa Jolla, United States
- David Geffen School of Medicine at UCLAVerified postcodeLos Angeles, United States
- NewportNativeMD, IncVerified postcodeNewport Beach, United States
- Palmtree Clinical Research, Inc.Verified postcodePalm Springs, United States
- UC Davis Health Medical CenterVerified postcodeSacramento, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- Stanford University School of MedicineVerified postcodeStanford, United States
Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a serious lung condition where scar tissue builds up in the lungs, making them stiff and hard to breathe. The cause is unknown ('idiopathic').
What is treprostinil?
Treprostinil is a medicine that helps open up blood vessels in the lungs, which can make breathing easier for some lung conditions. In this study, it's given as an inhaled mist.
How long will I need to be in the study?
The study could last for up to six years, depending on various factors, including your health and if the medicine becomes widely available.
Will I know if I'm getting the medicine or a dummy treatment?
This is an 'open-label' study, meaning everyone receives the active medicine, treprostinil. You will not be given a dummy treatment.
Why is this study important?
It helps researchers understand the long-term safety and effects of treprostinil for people with serious lung scarring conditions, which is crucial for developing new treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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