Active not recruitingPHASE2INTERVENTIONAL

Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine

This study, called Clairleaf™, is for adults aged 18 and over who have bronchiectasis, a condition that affects your lungs. It's for people who have already taken part in a previous study with a medicine called BI 1291583. The main goal is to understand if this medicine helps people with bronchiectasis over a long period and to see how well they tolerate it. Some participants will continue on the same dose of BI 1291583, while others who previously took a dummy pill (placebo) will be given a dose of the actual medicine. You would take a tablet once a day for up to a year, and there will be regular check-ups at the hospital and phone calls to monitor your health and symptoms.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Boehringer Ingelheim

Enrolment target

268

Start

08 Sep 2023

Estimated completion

31 Mar 2027

Bronchiectasis

What is this study about?

This study is looking into a medicine called BI 1291583 for people who have a lung condition called bronchiectasis. Bronchiectasis causes your airways to become permanently wider, which can lead to a build-up of mucus and make you more prone to lung infections. This particular study is a follow-up for people who have already participated in an earlier study involving BI 1291583, either called Airleaf™ or Clairafly™.

The main purpose of this study is to understand if taking BI 1291583 for a longer time can help manage bronchiectasis and if it's safe and well-tolerated over a longer period. Doctors want to see if the medicine helps to reduce symptoms and improve the overall health of people with this condition. By continuing to study this medicine, researchers hope to gather important information that could potentially help many people with bronchiectasis in the future.

Participants who were already taking BI 1291583 in the previous study will continue with the same dose. For those who were taking a 'dummy' pill (placebo) in the earlier study, they will now be randomly assigned to receive a low, medium, or high dose of BI 1291583. This method helps ensure the study results are fair and reliable. The study will last for up to one year, allowing researchers to observe the long-term effects of the medicine.

Key takeaways

This study is for adults with bronchiectasis who were in a previous BI 1291583 study.
It aims to see how BI 1291583 works long-term and how well it is tolerated.
You would take a tablet once a day for up to one year.
Regular clinic visits and phone calls will monitor your health.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. A key requirement is that you must have already completed the full treatment period of one of the previous studies for BI 1291583, either the Airleaf™ or Clairafly™ study.

There are also some health checks to make sure the study is safe for you. For example, your liver and kidney function will be checked, and your blood cell count will be reviewed. If you have certain severe liver or kidney problems, or if your blood counts are too low, you might not be able to join. Also, if you have a new diagnosis of certain immune conditions or certain lung conditions, you might not be able to take part.

Women who could become pregnant must agree to use effective birth control methods during the study. Before you join, a doctor will carefully review your medical history and the results from your previous study to confirm if this study is right for you.

Quick self-check

Are you 18 years old or older?
Do you have bronchiectasis?
Did you fully complete the previous Airleaf™ or Clairafly™ study?
Are you able to attend appointments at the study clinic?
Are you willing to use effective birth control if you are a woman who could become pregnant?

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 asked to take a BI 1291583 tablet once a day for up to an entire year. The dose you receive will depend on whether you took the active medicine or a dummy pill in the previous study. You will visit the study clinic 10 times over the year, where doctors will check your health, ask about any symptoms you're experiencing, and follow up generally. In between visits, you'll also receive 4 phone calls from the study staff to check in on you. The total duration of your participation will be up to one year of taking the medicine and attending these appointments.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to the study medicine for a longer period, which could help manage your bronchiectasis symptoms. However, like all medicines, BI 1291583 may have side effects, and not everyone experiences a benefit. Potential risks include any side effects from the medication itself and the usual inconveniences of attending clinic visits and blood tests. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (102)

Newport Native MD, Inc
Newport Beach, United States
University of California Davis
Sacramento, United States
Malcom Randall VA Medical Center
Gainesville, United States
University of Florida Health Jacksonville
Jacksonville, United States
University of Kansas Medical Center
Kansas City, United States
New York University Langone Medical Center
New York, United States
University of Cincinnati
Cincinnati, United States
Medical University of South Carolina
Charleston, United States
Metroplex Pulmonary & Sleep Center
McKinney, United States
IMA Clinical Research San Antonio
San Antonio, United States
University of Texas Health Science Center at Tyler
Tyler, United States
Macquarie University
Macquarie Park, Australia

+90 more sites — see the official record for the full list.

Common questions

What is bronchiectasis?

Bronchiectasis is a long-term lung condition where your airways become permanently wider and damaged. This can make you cough up mucus and get chest infections more easily.

What is BI 1291583?

BI 1291583 is a medicine being tested to see if it can help people with bronchiectasis. This study is looking at its long-term effects and safety.

Who can join this study?

This study is for adults over 18 who have bronchiectasis and have already fully completed a previous study with BI 1291583 (either Airleaf™ or Clairafly™).

Will I get the actual medicine or a dummy pill?

If you were on a dummy pill (placebo) in the previous study, you will now be randomly given BI 1291583. If you were on BI 1291583 before, you'll continue on the same dose.

How long does the study last?

Your involvement in the study, including taking the medicine and attending appointments, will last for up to one year.