Study on Long-Term Safety and Efficacy of BI 1291583 in Patients with Bronchiectasis

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a medication called BI 1291583 in people with a lung condition known as bronchiectasis. Bronchiectasis is a disease where the airways in the lungs become widened and scarred, leading to symptoms like coughing and difficulty breathing. The study involves taking oral doses of BI 1291583, which is a tablet form of medication, to see how it affects patients over time.

Participants in this study will receive either the medication BI 1291583 or a placebo, which looks like the medication but does not contain the active ingredient. The purpose of the study is to evaluate the safety of the medication by monitoring any side effects that occur during the trial. The study will also look at how the medication affects the time it takes for a lung flare-up, known as a pulmonary exacerbation, to occur and how often these flare-ups happen.

The study will last for up to 12 months, during which participants will take the medication daily. The trial is designed to be a roll-over study, meaning it includes people who have already participated in a previous study with BI 1291583. This approach helps researchers understand the long-term effects of the medication in a real-world setting. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the medication’s impact on their condition.

1 joining the study

Upon joining the study, you will be required to provide a signed and dated written informed consent. This is to ensure that you understand the study and agree to participate according to the guidelines of Good Clinical Practice and local legislation.

2 medication administration

You will be assigned to take an oral medication called BI 1291583. The dosage will be either 1 mg, 2.5 mg, or 5 mg, depending on the group you are placed in. This medication is taken once daily.

In some cases, you may receive a placebo, which looks like the medication but does not contain the active substance. This is to help compare the effects of the medication.

3 monitoring and assessments

Throughout the trial, your health will be closely monitored. This includes regular check-ups to assess any side effects or changes in your condition.

The main focus is to evaluate the safety of the medication by observing any treatment-emergent adverse events, which are any new or worsening health issues that occur during the trial.

4 tracking exacerbations

The study will also track the time to your first pulmonary exacerbation, which is a worsening of your lung condition, from the start of the medication until the end of the trial.

The rate of these exacerbations will be recorded to understand how often they occur during the study period.

5 completion of the trial

The trial is expected to continue until March 30, 2026. Upon completion, you will have a final assessment to evaluate your overall health and any effects of the medication.

Who Can Join the Study?

  • Patients who have completed the treatment period in the Phase II trial (identified as 1397-0012 or 1397-0013) as planned.
  • Both male and female patients can participate. Women who can have children must be ready and able to use highly effective birth control methods that have a low failure rate (less than 1% per year) when used correctly, along with one barrier method like a condom. Men must use male contraception (such as a condom) or practice sexual abstinence if their partner is a woman who can have children.
  • Patients must provide a signed and dated written informed consent before joining the trial, following Good Clinical Practice (GCP) and local laws.

Who Cannot Join the Study?

  • Patients with a history of Bronchiectasis cannot participate.
  • Patients who have experienced any treatment-emergent adverse events (TEAEs) during previous treatments are excluded. TEAEs are side effects or reactions that occur after starting a new treatment.
  • Patients who are part of a vulnerable population are not eligible. This term refers to groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
IRCCS Humanitas Research Hospital Rozzano Italy
Lungenfachklinik Immenhausen Germany
University Hospital Jena KöR Jena Germany
Katholieke Universiteit te Leuven Leuven Belgium
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Rigas 1. slimnica SIA Riga Latvia
University General Hospital Of Ioannina Ioannina Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Universitair Ziekenhuis Gent Gent Belgium
Daugavpils regionala slimnica SIA Daugavpils Latvia
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Klinikum Konstanz GmbH Konstanz Germany
Pauls Stradins Clinical University Hospital Riga Latvia
Medical Center Hera EOOD Sofia Bulgaria
Prvni plicni ambulance s.r.o. Prague Czechia
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Semmelweis University Budapest Hungary
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Ludwig Maximilian University Of Munich Munich Germany
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Aalborg University Hospital Aalborg Denmark
Klinische Forschung Berlin GbR Berlin Germany
Veselibas centru apvieniba AS Riga Latvia
Rigshospitalet Copenhagen Denmark
Gelre Hospitals Zutphen The Netherlands
Medical Center Zdrave-1 OOD Kozloduy Bulgaria
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Deutsches Herzzentrum Berlin Berlin Germany
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hospital De Merida Merida Spain
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Veselibas centru apvieniba AS Jurmala Latvia
Latvijas Universitates Mediciniskas Pecdiploma Izglitibas Instituts SIA Riga Latvia
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Infer-Med Kft. Pecs Hungary
MC Re Spiro OOD Razgrad Bulgaria
Screenmed Sp. z o.o. Piaseczno Poland
Odense University Hospital Odense Denmark
Region Sjaelland Holbæk Denmark
Hhsnawqf Hmpstuzl Hvidovre Denmark
Cbzcadsrq Hcqmnicw Trieste Italy
Mxlbzix Ceaocw Hzxv Emda Montana Bulgaria
Abrgggohn Uxh Amsterdam The Netherlands
Pugkkdtseuk Apmtbkcpqnleyvafrzggiombspfmyq Apgwvxqyzphj Sug z ocnp Swidnik Poland
Hgvgrlgz Vamz dkgruano Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
10.06.2023
Bulgaria Bulgaria
Not recruiting
10.06.2023
Czechia Czechia
Not recruiting
10.06.2023
Denmark Denmark
Not recruiting
10.06.2023
France France
Not recruiting
10.06.2023
Germany Germany
Not recruiting
10.06.2023
Greece Greece
Not recruiting
10.06.2023
Hungary Hungary
Not recruiting
10.06.2023
Italy Italy
Not recruiting
10.06.2023
Latvia Latvia
Not recruiting
10.06.2023
Poland Poland
Not recruiting
10.06.2023
Portugal Portugal
Not recruiting
10.06.2023
Spain Spain
Not recruiting
10.06.2023
The Netherlands The Netherlands
Not recruiting
10.06.2023

Trial locations

BI 1291583 is an experimental medication being tested for its safety and effectiveness in treating patients with bronchiectasis. Bronchiectasis is a lung condition where the airways become widened and scarred, leading to mucus build-up and frequent lung infections. This medication is taken orally, which means it is swallowed in the form of a pill or liquid. The goal of using BI 1291583 in this trial is to see if it can help reduce symptoms and improve lung function in people with this condition. The study is also focused on monitoring any side effects that patients might experience while taking this medication over a long period. This helps researchers understand how safe the medication is for long-term use.

Investigated diseases:

Bronchiectasis – Bronchiectasis is a chronic condition where the walls of the bronchi, the large air passages from the trachea to the lungs, become permanently widened. This widening is often due to inflammation and infection, leading to a cycle of damage and further infection. As the disease progresses, the airways lose their ability to clear out mucus, resulting in frequent lung infections and blockages. Patients often experience a persistent cough, production of large amounts of sputum, and shortness of breath. Over time, the repeated infections and inflammation can cause further damage to the lung tissue. The condition can lead to a decline in lung function and increased respiratory symptoms.

Trial ID:
2023-503290-38-00
Protocol code:
1397-0017
Trial Phase:
Therapeutic exploratory (Phase II)

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