Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis
This study, called AP01, is looking into a new way to deliver pirfenidone, a medicine already used for some lung conditions. Instead of taking it as a tablet, this study uses a special inhaler to get the medicine directly into the lungs. The study involves people with progressive, fibrosing interstitial lung diseases (ILDs), including Idiopathic Pulmonary Fibrosis (IPF). These conditions cause scarring in the lungs, making it harder to breathe. The main goal is to check how safe this inhaled pirfenidone is and to see if people experience any side effects. Researchers will also be looking at overall health and any serious problems or deaths during the study. This is an early-stage study, meaning it's exploring new options for treatment.
At a glance
What is this study about?
This study, called AP01, is focused on exploring a new way to give medicine to people who have certain lung conditions. Specifically, it's for people with progressive, fibrosing interstitial lung diseases (ILDs). These are a group of illnesses that cause scarring in the lungs, which can make it increasingly difficult to breathe over time. One common type of ILD is Idiopathic Pulmonary Fibrosis, or IPF.
The medicine being tested is called pirfenidone. It's already approved for use in some people with IPF, usually taken as a tablet or capsule. However, this study is testing a different method: giving pirfenidone as a solution that you breathe in using a special inhaler. The idea behind this is to deliver the medicine directly into the lungs, which might be more effective or have fewer side effects compared to taking it by mouth.
Because this is an early-stage study (Phase II), the main focus is on safety. Researchers want to carefully watch how people react to the inhaled pirfenidone, noting any side effects or problems that might happen. They will also keep track of overall health and any serious events. This type of study is important for understanding if a new treatment method is safe enough to be tested further in larger groups of people.
Key takeaways
- This study tests an inhaled version of pirfenidone for lung scarring conditions.
- It aims to see if delivering the medicine directly to the lungs is safe.
- It's for adults with progressive, fibrosing interstitial lung diseases like IPF.
- Both men and women aged 18 and older can be considered.
- The main goal is to monitor safety and side effects, as it's an early-stage study.
Who may be eligible?
To be considered for this study, you must be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part if they meet other criteria.
Both men and women are welcome to participate in this study. The researchers want to include a diverse group of people to understand how the inhaled medicine affects different individuals.
Beyond age and gender, it's important that you have a diagnosis of a progressive, fibrosing interstitial lung disease (ILD), which includes conditions like Idiopathic Pulmonary Fibrosis (IPF). There will be other specific health checks and tests done by the study doctors to make sure the treatment is suitable and safe 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 a progressive lung scarring condition (like IPF)?
- Are you able to use an inhaler to take medication?
- Are you willing to attend regular clinic appointments for check-ups?
What does participation involve?
If you decide to take part in this study, you will be given the study medicine, pirfenidone, as a solution to inhale. You will receive instructions on how to use the inhaler properly. You'll have regular visits to the study clinic where doctors and nurses will monitor your health closely.
During these visits, you can expect to have various assessments. These might include breathing tests to check your lung function, blood tests to monitor your general health and how your body is reacting to the medicine, and physical examinations. You will also be asked about any new symptoms or how you are feeling, especially any side effects.
The study team will explain how long you would need to take the medicine and how often you'd have appointments. They will also tell you about any follow-up appointments after you stop taking the study medicine. The total length of your participation will be fully discussed before you make any decisions.
Potential risks and benefits
Locations (3)
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Common questions
What is pirfenidone?
Pirfenidone is a medicine already used to treat certain lung scarring conditions, often taken as tablets. This study is testing it in an inhaled form.
What kind of lung conditions is this study for?
This study is for people with lung conditions that cause progressive scarring, including Idiopathic Pulmonary Fibrosis (IPF).
What does 'inhaled solution' mean?
It means the medicine is in a liquid form that you breathe in using a special device, rather than swallowing a pill.
Is this a new medicine?
No, pirfenidone already exists, but the way it's being given (inhaled) is new and being tested for safety in this study.
Why is safety the main focus?
Because this is an early-stage study, researchers first need to carefully check if giving the medicine this new way is safe for people and what side effects might occur.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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