Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
This study is investigating a new inhaled medicine called Treprostinil Palmitil Inhalation Powder (TPIP) for adults who have high blood pressure in their lungs (Pulmonary Hypertension) caused by scarring in their lungs (Interstitial Lung Disease, or PH-ILD). The main goal is to find out if taking TPIP once a day for 24 weeks helps people improve their ability to exercise, specifically how far they can walk in six minutes, compared to those taking a placebo (a dummy medicine without any active ingredient). This is a Phase 3 study, meaning it's one of the final stages of testing before a medicine might be approved for wider use. Researchers are also checking how safe the medicine is.
At a glance
What is this study about?
This study is about a new inhaled medicine called Treprostinil Palmitil Inhalation Powder, or TPIP for short. It's for adults who have a specific lung problem where they have high blood pressure in the arteries of their lungs, and this is caused by scarring in the lung tissue. This condition is often called Pulmonary Hypertension associated with Interstitial Lung Disease, or PH-ILD.
The main aim of this study is to see if TPIP can help people with PH-ILD improve their ability to exercise. Researchers will measure this by seeing if people can walk further in six minutes after taking the medicine for 24 weeks, compared to those who take a placebo (a control treatment that looks like the real medicine but has no active ingredients). They will also carefully monitor any side effects to make sure the medicine is safe.
Finding new ways to help people with PH-ILD is really important because this condition can make daily activities much harder. If TPIP proves to be effective and safe, it could offer a new treatment option for managing the symptoms and improving the lives of people living with this challenging lung condition.
Key takeaways
- This study is testing an inhaled medicine (TPIP) for high blood pressure in the lungs caused by lung scarring (PH-ILD).
- It aims to see if the medicine helps people walk further in 6 minutes.
- Participants will take the medicine or a dummy medicine for 24 weeks.
- Regular health checks, scans, and walking tests are part of the study.
- It's a Phase 3 study, meaning it's a key step towards potential new treatments.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. You need to have been diagnosed with pulmonary hypertension (high blood pressure in your lungs) that is linked to scarring in your lungs (interstitial lung disease, or ILD). This diagnosis must have been confirmed by special scans and heart tests within the last year.
You also need to be able to walk a certain distance – at least 100 meters but no more than 500 meters – in a six-minute walking test. If you are already taking medicines for your lung condition or other related illnesses, you should have been on a stable dose for at least one to three months before joining. Your doctor will carefully check all your medical records to make sure you meet these specific requirements.
There are also reasons why you might not be able to join. For example, if you have other types of pulmonary hypertension not related to ILD, or if you have certain heart problems or severe breathing conditions like COPD (chronic obstructive pulmonary disease). The study doctors will review your full health history to determine if this study is suitable for you.
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 18 years old or older?
- Do you have a diagnosis of high blood pressure in your lungs (Pulmonary Hypertension) caused by scarring in your lungs (Interstitial Lung Disease)?
- Can you walk between 100 and 500 meters in a 6-minute walking test?
- If you take other medicines for your lung condition, have you been on a stable dose for at least 30 to 90 days?
- Do you have certain heart conditions or other types of lung disease like severe COPD?
What does participation involve?
If you decide to join this study, you will either receive the new inhaled medicine (TPIP) or a placebo (a dummy medicine) for 24 weeks. Neither you nor your study doctor will know which one you are taking. You'll need to take the study medicine once a day. Throughout the 24 weeks, you'll have regular visits to the clinic for medical checks, scans, and blood tests. You will also repeat the six-minute walking test several times to see how your exercise ability changes. After the main 24-week treatment period, there will be follow-up appointments to ensure your continued well-being. The total duration of your participation in the study, including follow-up, will be explained by the study team.
Potential risks and benefits
Locations (109)
- USA010Verified postcodeLos Angeles, United States· Not yet recruiting
- USA001Verified postcodeSanta Barbara, United States· Not yet recruiting
- USA006Verified postcodeNaples, United States· Recruiting
- USA026Verified postcodeSt. Petersburg, United States· Not yet recruiting
- USA002Verified postcodeKansas City, United States· Not yet recruiting
- USA003Verified postcodeBend, United States· Recruiting
- USA013Verified postcodePhiladelphia, United States· Not yet recruiting
- USA008Verified postcodeRichmond, United States· Not yet recruiting
- ARG002UnverifiedCiudadAutonoma de Buenos Aires, Argentina· Not yet recruiting
- ARG003Verified postcodeRío Cuarto, Argentina· Not yet recruiting
- ARG008Verified postcodeSan Miguel de Tucumán, Argentina· Not yet recruiting
- ARG004Verified postcodeCórdoba, Argentina· Not yet recruiting
Common questions
What is PH-ILD?
PH-ILD is high blood pressure in the arteries of your lungs that is caused by scarring in your lung tissue (Interstitial Lung Disease).
What is Treprostinil Palmitil Inhalation Powder (TPIP)?
TPIP is a new medicine that is breathed in as a powder, being tested to treat PH-ILD.
What is a Phase 3 study?
A Phase 3 study is a later stage of research where a new medicine is tested on a larger group of people to confirm its effectiveness and safety before it might be approved for general use.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real treatment but does not contain any active drug. It helps researchers compare the effects of the active medicine.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving TPIP or the placebo.
How to find out more
Insmed Medical Information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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