Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase IIa/IIb, randomised, double blind, placebo-controlled, parallel-group dose-finding study to examine the efficacy and safety of BI 1839100 administered orally over a 12-week treatment period in patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis with clinically meaningful cough

This research study is testing a new medication, BI 1839100, for people living with specific lung conditions called Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). These conditions can cause a persistent and bothersome cough. The main goal is to find out if this new medicine can help reduce how often people cough and if it's safe to take. Participants will take either the study medicine or a dummy pill (placebo) for 12 weeks. Researchers will carefully watch for changes in coughs and any side effects. This is a "Phase II" study, meaning it's an important step in understanding how effective and safe the new medicine might be before it can be widely used.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Enrolment target

100

Start

23 Aug 2024

Progressive pulmonary fibrosis (PPF)Idiopathic pulmonary fibrosis (IPF)

What is this study about?

This study is looking into a new medicine, called BI 1839100, for people who have certain lung conditions. These conditions are called Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). Both can cause scarring in the lungs, which can lead to a persistent and difficult cough.

The main aim of this study is to see if BI 1839100 can help reduce how often people cough. Researchers also want to make sure the medicine is safe to use. You might receive the new medicine or a 'dummy' pill (called a placebo). A placebo looks exactly like the real medicine but contains no active ingredients. This helps researchers compare the effects accurately.

The study will last for 12 weeks, and during that time, your cough will be carefully monitored. The hope is that this research will lead to better ways to manage the cough associated with these challenging lung conditions, improving the daily lives of those affected.

Key takeaways

This study is testing a new medicine for certain lung conditions.
It aims to see if the medicine can reduce persistent coughing.
Participants will take either the study medicine or a dummy pill.
Careful monitoring of cough and safety will happen over 12 weeks.
This is an important step in developing new treatments for lung fibrosis.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. Both men and women can take part. The study is specifically for people who have been diagnosed with either Idiopathic Pulmonary Fibrosis (IPF) or Progressive Pulmonary Fibrosis (PPF) and have a cough that causes them problems.

There will be other specific health requirements for taking part, which the study team will discuss with you. These are in place to make sure the study is safe for everyone involved and that the results are as clear as possible.

For example, certain other medical conditions or medications might mean you can't join. The study doctors will review your full medical history to confirm if the study is a good fit 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?
Have you been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) or Progressive Pulmonary Fibrosis (PPF)?
Do you have a cough related to your lung condition that is troublesome?
Are you able to attend regular clinic appointments for 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new study medicine (BI 1839100) or a placebo, which looks identical but contains no active drug. You would take this medicine by mouth for 12 weeks. During this time, you would have several visits to the clinic so the study team can check on your health and how the medicine is affecting your cough. These visits will involve various checks, such as measuring your cough frequency, asking about your cough severity, and conducting lung function tests. You would also have blood tests and other assessments to monitor your general health and watch for any side effects. After the 12-week treatment period, there will be follow-up visits to ensure your well-being. The total duration of your involvement, including all visits, will be explained fully by the study team.

Potential risks and benefits

Taking part in this study could offer some potential benefits. You might receive a new treatment that could help reduce your cough, and you'd receive close medical attention throughout the study. However, like all medicines, BI 1839100 may have side effects, which could be unpleasant or serious. There's also a chance you might receive the placebo and not the active drug. The study team will explain all known risks before you decide to participate. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Belgium
—
Unverified
Czechia
—
Unverified
Poland
—
Unverified
Germany
—
Unverified
Sweden
—
Unverified
Spain
—
Unverified
Italy
—
Unverified
Finland
—
Unverified
Austria
—
Unverified
France
—
Unverified
Greece
—
Unverified
Denmark

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a lung disease where scar tissue builds up in your lungs, making it harder to breathe. 'Idiopathic' means the cause is unknown.

What is Progressive Pulmonary Fibrosis (PPF)?

PPF is another lung condition where scarring in the lungs gets worse over time. It can be caused by various factors, not just unknown ones.

What does 'placebo-controlled' mean?

It means some people will get the study medicine, and others will get an identical-looking dummy pill with no active ingredient. This helps us see if the medicine itself is causing any changes rather than other factors.

What is a 'Phase II' study?

Phase II studies are an early stage of testing new medicines. They focus on finding the right dose, checking if the medicine works, and looking for side effects in a larger group of people than in a Phase I study.

Will I know if I'm getting the real medicine or the placebo?

No, both you and the study team won't know who is receiving the active medicine and who is receiving the placebo. This is called 'double-blind' and ensures the results are not influenced by expectations.