AuthorisedTherapeutic exploratory (Phase II)Interventional

Proof-of-principle study of inhaled pulmonary surfactant in patients with Idiopathic Pulmonary Fibrosis (INSURF-IPF)

This research trial, called INSURF-IPF, is looking into a new way to treat Idiopathic Pulmonary Fibrosis (IPF), a serious lung condition. The study is testing an inhaled medication called ALVEOFACT®, which is a type of 'pulmonary surfactant'. Surfactant is a natural substance in your lungs that helps them work properly. Researchers want to see if inhaling this medication can improve how well people with IPF breathe. They will measure various aspects of lung function and keep a close eye on any side effects. This is a Phase II study, meaning it's an early stage to explore how effective and safe this treatment might be.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Philipps-Universitaet Marburg

Enrolment target

Start

05 Jul 2024

Idiopathic pulmonary fibrosis

What is this study about?

This study is called INSURF-IPF, which stands for "Proof-of-principle study of inhaled pulmonary surfactant in patients with Idiopathic Pulmonary Fibrosis." Idiopathic Pulmonary Fibrosis (IPF) is a lung disease that causes scarring in the lungs, making it harder to breathe over time. The word 'idiopathic' means we don't currently know why it happens.

Researchers are investigating a new inhaled treatment for IPF. This treatment uses a substance called ALVEOFACT®, which is a type of 'pulmonary surfactant'. Think of surfactant like a natural soap in your lungs that helps keep the tiny air sacs (alveoli) open and working efficiently. In IPF, the lungs can become stiff, and the air sacs might not work as well. The idea is that delivering surfactant directly to the lungs through an inhaler might help improve breathing for people with this condition.

This is an early-stage study (Phase II), which means it's designed to see if the treatment works in a small group of people and if it's safe. The main goal is to check how this inhaled medicine affects how much air your lungs can hold and how well they can push air out. They will also look at many other details about how your lungs are working and whether the treatment causes any unwanted side effects.

Key takeaways

This study is testing an inhaled treatment for Idiopathic Pulmonary Fibrosis (IPF).
It uses a substance called ALVEOFACT®, a type of lung surfactant.
The main goal is to see if it improves how well your lungs work.
It's an early-stage (Phase II) study to check effectiveness and safety.
Participation involves regular lung function tests and health checks.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or over. There is no upper age limit, and the study is open to both men and women.

The most important requirement is that you have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF). Your medical team at the hospital would usually confirm this diagnosis.

There might be other health conditions or medications that would prevent you from taking part, but the study team would discuss these specific details with you during a screening visit to make sure it's safe for you to join.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF)?
Are you generally able to attend regular hospital visits?
Do you understand that this is a research study with no guaranteed benefits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive the study medication, ALVEOFACT®, as an inhaled treatment. The researchers would regularly check your lung function using various breathing tests. These tests are designed to measure things like how much air you can breathe in and out, and how quickly. You would also have blood tests and other checks to monitor your general health and see if the treatment is causing any side effects. You would also be asked to fill in some questionnaires about your daily life, your breathing, and how you feel, which helps the researchers understand the impact of the treatment. The total duration involves several phases of inhalation, and precise timings will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing a new treatment that isn't yet widely available, and it could contribute to important medical research for IPF. However, there's no guarantee the treatment will improve your condition, and it might have side effects that are not yet fully known. Any potential risks will be carefully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Germany

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a lung disease where your lungs become scarred and stiff, making it harder to breathe. 'Idiopathic' means the cause is unknown.

What is a 'pulmonary surfactant'?

It's a natural substance in your lungs that helps keep the tiny air sacs open so you can breathe easier. This study is testing an inhaled version of it.

What does a 'Phase II' study mean?

It's an early stage of research. It means the treatment has passed basic safety tests, and now researchers are exploring if it works and what its best dose might be in a small group of people.

Will I receive the actual treatment or a dummy treatment?

The information provided doesn't specify if there's a 'dummy' treatment (placebo) arm. You should ask the study team about this, as it's common in trials.

How often would I need to visit the hospital?

The study involves different 'inhalation phases' and various tests. The study team will provide a detailed schedule of visits if you are eligible.