A participant - and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in patients with idiopathic pulmonary fibrosis
This important study is investigating new ways to treat Idiopathic Pulmonary Fibrosis (IPF), a serious lung disease. Researchers are testing a new medicine called LTP001 against a placebo, which is a dummy pill, to see how well it works and if it's safe. Participants will be given either LTP001 in different doses or the placebo, and neither they nor their doctors will know which treatment they are receiving until the study ends. The main goal is to find out if LTP001 can help slow down the progression of IPF, specifically by looking at changes in lung function over 26 weeks. The study will also monitor participants' overall health, quality of life, and any side effects to make sure the treatment is well-tolerated.
At a glance
What is this study about?
This study is about a lung condition called Idiopathic Pulmonary Fibrosis, or IPF. IPF causes scarring in the lungs, making it harder to breathe over time. We don't yet have a cure for IPF, so researchers are always looking for new treatments that can slow down the disease or make people feel better.
In this study, doctors are investigating a new medicine called LTP001. They want to see if it can help people with IPF. To do this, some people will get the new medicine, while others will get a 'placebo' – this is an inactive pill that looks just like the real medicine. This is a very common and important way to test new medicines, as it helps doctors reliably see if the new drug actually works better than no treatment at all. Neither you nor your study doctor will know whether you are taking the actual medicine or the placebo, which helps ensure the results are fair and unbiased.
The main thing the doctors will be looking at is how your lung function changes over 26 weeks. They use a test called Forced Vital Capacity (FVC), which measures how much air you can breathe out after taking a deep breath. They will also look at other things like your general health, how far you can walk, how your quality of life changes, and any side effects you might experience. This will help them understand if LTP001 is a safe and effective treatment for IPF.
Key takeaways
- This study investigates a new medicine, LTP001, for Idiopathic Pulmonary Fibrosis (IPF).
- It compares LTP001 to a dummy pill (placebo) to check effectiveness and safety.
- Participants will take the study medicine for about 26 weeks.
- Lung function will be regularly checked, along with general health and well-being.
- Both men and women aged 18 and over with IPF are invited to consider participating.
Who may be eligible?
To join this study, you generally need to be an adult, aged 18 or older. Both men and women are welcome to take part in the research. The doctors will also need to confirm that you have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF).
There will be other, more detailed health checks to make sure the study medicine is right and safe for you. These checks ensure that participating in the trial is suitable for your specific health situation and that the results of the study are clear and accurate.
- Are you 18 years old or older?
- Have you been diagnosed with Idiopathic Pulmonary Fibrosis (IPF)?
- Are you male or female?
- Are you able to attend regular clinic visits for about 26 weeks?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join the study, you'll be given either the new medicine, LTP001, or a dummy pill (placebo) in capsule form. You, along with your study doctor, won't know which one you're taking. You'll take these capsules for 26 weeks, which is about six months. During this time, you'll have regular visits to the clinic.
These visits will involve checks like measuring your breathing with lung function tests (like the FVC test), physical examinations, blood tests, and checking your heart with an ECG. You'll also answer questionnaires about your symptoms and how you're feeling. All these assessments help the doctors understand how the treatment is affecting you and your condition. After the 26 weeks of treatment, there will likely be follow-up visits to ensure you remain well and to gather any final information.
Potential risks and benefits
Locations (4)
- —Germany
- —Czechia
- —Netherlands
- —Poland
Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a lung disease that causes scarring in the lungs, making it harder to breathe over time.
What is a 'placebo'?
A placebo is a dummy pill that looks like the real medicine but contains no active drug. It helps doctors see if the real medicine works better than no treatment.
How long will the treatment part of the study last?
The treatment part of the study will last for 26 weeks, which is about six months.
Will I know if I'm getting the new medicine or the placebo?
No, both you and your study doctor will not know which treatment you are receiving until after the study has finished.
What is the main thing the study is trying to find out?
The main goal is to see if the new medicine, LTP001, can slow down the disease by improving how your lungs work, specifically your breathing capacity.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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