Study on the Safety and Tolerance of BI 1291583 in Adults with Cystic Fibrosis Bronchiectasis

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What is this study about?

This clinical trial is focused on studying a condition known as cystic fibrosis bronchiectasis. This is a lung disease where the airways become damaged, leading to symptoms like persistent cough and frequent lung infections. The trial will test a new treatment called BI 1291583, which is taken as a tablet once a day. The study will compare the effects of this treatment to a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to see how well BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants will take the medication or placebo for 12 weeks. During this time, researchers will monitor the participants to see if they experience any side effects and how their bodies process the medication. The study will also involve the use of salbutamol sulfate, a common medication used to help open the airways in the lungs, which will be administered through inhalation.

Throughout the study, participants will have regular check-ups to ensure their safety and to gather information on how the treatment is working. The trial aims to provide valuable insights into the safety and effectiveness of BI 1291583 for treating cystic fibrosis bronchiectasis, potentially leading to better treatment options for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the patient meets the criteria for participation.

2 randomization

Participants are randomly assigned to receive either the BI 1291583 tablet or a placebo. This process is double-blind, meaning neither the patient nor the researchers know which treatment is being administered.

3 treatment phase

The treatment phase lasts for 12 weeks. During this period, patients take one tablet of BI 1291583 5 mg or a placebo once daily by mouth.

In addition to the tablet, patients may use salbutamol sulfate as needed for inhalation to manage symptoms.

4 monitoring and assessments

Throughout the trial, regular monitoring and assessments are conducted to evaluate safety and effectiveness. This includes checking for any side effects and measuring changes in lung function and other health indicators.

At week 8, a specific assessment is conducted to measure changes in neutrophil elastase activity in sputum.

5 follow-up

After completing the 12-week treatment phase, patients undergo a follow-up period lasting up to 16 weeks from the first drug administration. This includes additional assessments to monitor any ongoing effects of the treatment.

Who Can Join the Study?

Patients must be at least 18 years old when they sign the informed consent form.
Patients need to have a past clinical diagnosis of cystic fibrosis (CF), which is a genetic condition affecting the lungs and other organs. This diagnosis is confirmed by symptoms and a sweat test showing chloride levels of 60 mmol/L or higher, or by having two CF-causing gene mutations.
Patients must have a diagnosis of bronchiectasis (BE), which is a lung condition that causes coughing and mucus production. This diagnosis should be confirmed by a CT scan and a clinical history that matches BE symptoms. If past CT scans are not available, a new scan will be done during the screening. Past scans should not be older than 5 years.
Patients should have a history of lung flare-ups, known as pulmonary exacerbations, that required antibiotic treatment. In the year before the first visit, patients must have had either at least two flare-ups or at least one flare-up and a St. George’s Respiratory Questionnaire (SGRQ) Symptoms score of more than 40 at the first screening visit. For those on stable antibiotics for BE, at least one flare-up must have happened while on these antibiotics.
Patients must be able to provide samples of mucus from their lungs, either naturally or through a process called induced sputum.
Patients must sign and date a written informed consent form, following international guidelines and local laws, before joining the trial.
Both male and female patients can participate. Women who can have children must agree to use highly effective birth control methods that have a failure rate of less than 1% per year, along with one barrier method. Men must use male contraception, like condoms or abstain from sex, if their partner is a woman who can have children.

Who Cannot Join the Study?

Patients who do not have cystic fibrosis bronchiectasis cannot participate. This is a lung condition where the airways become damaged and widened.
Patients who are not within the specified age range cannot participate. The age range includes children and adults.
Both male and female patients are considered for participation, so gender is not an exclusion factor.
Patients who are part of a vulnerable population may not be eligible. A vulnerable population includes groups like children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
Deutsches Herzzentrum Berlin	Berlin	Germany
Vrije Universiteit Brussel	Jette	Belgium
Aohhtdnda Uqp	Amsterdam	The Netherlands
Alvfskdduf Pxqkahga Hljkiwis Dd Pzlua	Paris	France
Hxaajuzm Vlix dyjsoosa	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	28.02.2024
France	Not recruiting	28.02.2024
Germany	Not recruiting	28.02.2024
Italy	Not recruiting	28.02.2024
Spain	Not recruiting	28.02.2024
The Netherlands	Not recruiting	28.02.2024

Trial locations

Investigated drugs:

BI 1291583 is a medication being tested in this clinical trial. It is taken as one tablet once daily for 12 weeks. The trial aims to evaluate its safety and how well it is tolerated by patients with cystic fibrosis bronchiectasis. The study also looks at how the body processes the medication and its effects on the body.

Investigated diseases:

Cystic Fibrosis Bronchiectasis – Cystic fibrosis bronchiectasis is a condition where the airways in the lungs become damaged and widened due to the thick, sticky mucus associated with cystic fibrosis. This mucus can lead to repeated lung infections and blockages, causing inflammation and further damage to the airways. Over time, the airways lose their ability to clear mucus effectively, leading to persistent cough, difficulty breathing, and frequent respiratory infections. The disease progresses as the cycle of infection and inflammation continues, causing more damage to the lung tissue. Patients may experience symptoms such as chronic cough, production of sputum, and shortness of breath. The condition is considered a rare disease and requires ongoing management to help control symptoms and prevent complications.

Trial ID:

2022-502835-21-00

Protocol code:

1397-0013

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Tolerance of BI 1291583 in Adults with Cystic Fibrosis Bronchiectasis

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