NAL ER IPF Respiratory Function and Safety Study
This study is investigating a new medication, NAL ER, for individuals with Idiopathic Pulmonary Fibrosis (IPF). The main goals are to check how safe NAL ER is and what different doses people can handle without serious side effects. Researchers also want to see if this new medicine has any positive effects on breathing and lung function for those with IPF. Participants will be given either NAL ER or a dummy medicine (placebo). This is an early-stage study, meaning it's one of the first times this medication is being tested in people to ensure it's safe before larger studies are done.
At a glance
What is this study about?
This study is about a new medicine called NAL ER that could potentially help people living with Idiopathic Pulmonary Fibrosis (IPF). IPF is a serious lung condition that causes scarring in the lungs, making it harder to breathe over time. The main purpose of this study is to find out if NAL ER is safe for people to take and to understand what different amounts (doses) of the medicine can be given without causing too many problems. This is a very important first step in developing any new treatment.
Alongside checking for safety, the researchers also want to see if NAL ER has any effect on how well people's lungs are working. They will be measuring things related to breathing to see if there are any improvements or changes. Some participants will receive NAL ER, while others will receive a 'placebo', which looks like the study medicine but contains no active drug. This helps researchers understand the true effects of NAL ER compared to receiving no treatment at all.
This is an early-stage study, called a Phase 1 study. This means it's one of the first times this medicine is being tested in people with IPF. The information gathered will be crucial for deciding if NAL ER has enough promise to be studied further in larger groups of people. Every step in medical research is carefully monitored to protect the well-being of the people taking part.
Key takeaways
- This study tests a new medicine called NAL ER for Idiopathic Pulmonary Fibrosis (IPF).
- Its main goals are to check the safety and acceptable doses of NAL ER.
- Researchers will also look for any effects on breathing and lung function.
- Some participants will get NAL ER, others a dummy medicine (placebo).
- This is an early-stage (Phase 1) study.
- Participation involves time in a clinic and regular health checks.
Who may be eligible?
To join this study, people need to have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF) from a lung specialist, based on widely accepted medical guidelines. Their oxygen levels when resting should be healthy, and their lung capacity (how much air they can breathe out) should be at least 40% of what's expected for someone their age and size. Participants must be 18 years or older.
There are also some reasons why someone might not be able to join. For example, if they've had a sudden worsening of their IPF in the last three months, or if they currently have COVID-19. People with another lung disease like severe COPD, or those who use oxygen therapy every night, would also not be eligible. Also, anyone with a recent chest infection or certain sleep breathing problems would not be able to take part.
- Do I have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF)?
- Are my resting oxygen levels healthy (92% or higher)?
- Is my lung capacity (FVC) at least 40% of what's expected for my age and size?
- Have I been free of a sudden worsening of my IPF (exacerbation) for at least the last three months?
- Am I free of COVID-19 and recent chest infections?
- Do I only use oxygen in the daytime (no overnight oxygen)?
- Am I 18 years old or older?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve spending time at a special clinic called a clinical research unit (CRU). You would be given either the study medicine (NAL ER) or a dummy medicine (placebo). Throughout your time in the study, doctors and nurses would regularly check on your health and take measurements related to your breathing and lung function. These assessments would help them understand how the medicine is affecting your body. You would have follow-up visits after the main testing period to make sure you are doing well. The total duration of participation in the study, including initial checks and follow-up, would be made clear to you by the study team.
Potential risks and benefits
Locations (2)
- Mayo ClinicRochester, United States· Recruiting
- Medicines Evaluation Unit Ltd.Manchester, United Kingdom· Recruiting
Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a lung disease where scar tissue builds up in your lungs, making them stiff and increasingly difficult to breathe.
What is a 'placebo'?
A placebo looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is having an effect.
Why is this called a 'Phase 1' study?
Phase 1 studies are the first stage of testing a new medicine in people. They mainly focus on checking if the medicine is safe and what doses can be tolerated.
Will I know if I'm getting NAL ER or the placebo?
No, in this type of study, participants usually don't know whether they are receiving the study medicine or the placebo. This helps ensure fair and unbiased results.
How long will I need to be in the study?
The exact duration of the study for each participant will be explained by the study team, including screening, treatment, and follow-up visits.
How to find out more
Connie Crum
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.