This clinical trial focuses on evaluating a new medication called BI 1291583 for people with bronchiectasis, a condition where the airways in the lungs become permanently widened, damaged, and scarred. People with bronchiectasis often experience persistent cough, excess mucus production, and frequent chest infections. The study aims to determine if the medication is effective in reducing the number of lung-related flare-ups compared to placebo.
The study medication comes in the form of film-coated tablets that are taken by mouth once daily. The treatment period lasts up to 76 weeks, during which participants will receive either BI 1291583 at a dose of 2.5 mg or a matching placebo. This is part of what is called a Phase III study, which is one of the final stages of testing a new medication before it can be approved for general use.
Throughout the study, participants will be monitored for improvements in their condition, particularly focusing on how often they experience pulmonary exacerbations (sudden worsening of respiratory symptoms that require antibiotic treatment). The study will also track changes in breathing tests and how the treatment affects participants’ quality of life related to their respiratory symptoms.
1Initial evaluation
You will undergo evaluation to confirm your bronchiectasis diagnosis through CT scan (if your previous scan is older than 5 years)
Your ability to produce sputum will be assessed
Your medical history will be reviewed, particularly focusing on previous pulmonary exacerbations (lung infection episodes requiring antibiotics)
2Treatment assignment
You will be randomly assigned to receive either BI 1291583 or placebo
The medication will be in the form of film-coated tablets
The dosage will be 2.5 mg taken once daily
3Treatment period
The treatment duration will be up to 76 weeks (approximately 1.5 years)
You will take the assigned medication orally once per day
Regular assessments will monitor your lung function and respiratory symptoms
Your quality of life related to respiratory symptoms will be evaluated
Any pulmonary exacerbations during the study period will be documented
4Key evaluations
Your lung function will be measured at week 52 using tests called FEV1 (amount of air you can forcefully exhale in one second) and FVC (total amount of air you can exhale)
Your respiratory symptoms and quality of life will be assessed using standardized questionnaires
The frequency and severity of any lung infections will be monitored throughout the study
5Study completion
The study will evaluate how the medication affects the rate of lung infections over the 76-week period
Final assessments will be conducted to compare your condition with the initial measurements
Who Can Join the Study?
Must be at least 18 years old when signing the consent form
Both men and women can participate. Women who can become pregnant must use highly effective birth control methods with less than 1% failure rate, plus one barrier method
Must provide written informed consent to participate in the study
Must have symptoms typical for bronchiectasis, such as:
Cough
Ongoing mucus production
Repeated chest infections
Must have bronchiectasis confirmed by CT scan (a detailed X-ray of the chest). The CT scan must be from the last 5 years or a new one will need to be done
Must be able to produce sputum (mucus coughed up from lungs) for testing
Must have a history of pulmonary exacerbations (flare-ups of lung symptoms) that required antibiotics, specifically either:
At least 2 flare-ups in the past 12 months, or
At least 1 flare-up and a high symptom score (above 40) on a special breathing questionnaire
For patients already taking regular antibiotics or specific genetic therapy (CFTR-MT), at least one flare-up must have occurred since starting this treatment
Who Cannot Join the Study?
Age below 18 years old or above 80 years old
Pregnant or breastfeeding women
History of severe allergic reactions to medications
Active lung infection at the time of screening
Major surgery within 3 months before the study
Current participation in other clinical trials
Significant liver problems (as shown in blood tests)
Severe kidney disease requiring dialysis (a process of removing waste from blood when kidneys don’t work properly)
Active tuberculosis (a serious bacterial infection primarily affecting the lungs)
Inability to perform breathing tests
Known or suspected lung cancer
History of organ transplantation
Serious heart conditions
Unable to take oral medications
Mental conditions that could interfere with study participation
Based on the provided trial information, I can only identify one medication:
BI 1291583 is an investigational medication being studied for treating bronchiectasis, a condition where the airways in the lungs become damaged and widened. This medication is being tested to see if it can reduce the number of times patients experience worsening of their bronchiectasis symptoms (called pulmonary exacerbations). It is taken once daily as an oral medication.
Note: The trial also includes a placebo, which has been excluded as per the instructions.
Bronchiectasis – A chronic lung condition where the airways become abnormally widened and damaged, leading to mucus build-up in these areas. The condition causes the walls of the airways to become thickened from chronic inflammation and infection. People with bronchiectasis often experience persistent coughing that brings up thick mucus, recurrent chest infections, and breathlessness. The damaged airways lose their ability to clear mucus effectively, creating a cycle of infection and inflammation. Over time, this condition can affect larger portions of the lungs as more airways become damaged and dilated.
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