BI 1291583 for Bronchiectasis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new medicine, BI 1291583, can help people with bronchiectasis, a condition where the airways in the lungs become widened and scarred, leading to frequent infections and sputum production. Researchers randomly divide participants into two groups: one takes the new medicine, and the other takes a placebo (an inactive tablet). The study will compare the number of flare-ups between the two groups over about 1.5 years. Suitable candidates for this trial are those who produce sputum and have experienced bronchiectasis flare-ups requiring antibiotics. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on stable oral or inhaled antibiotics or CFTR-MT for bronchiectasis, you may continue them as long as you meet the other criteria.
Is there any evidence suggesting that BI 1291583 is likely to be safe for humans?
Research has shown that BI 1291583 is generally safe and well-tolerated. In an earlier study, participants taking BI 1291583 did not report any major safety issues. The study found a good balance between benefits and risks, with no significant side effects at the doses tested.
Additional research indicates that BI 1291583 helped reduce lung flare-ups in people with bronchiectasis, suggesting the treatment is both potentially effective and safe.
Overall, the available data supports the safety of BI 1291583 for those who have taken it in previous studies.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for bronchiectasis, which often involve antibiotics and airway clearance techniques, BI 1291583 is unique because it targets the underlying inflammatory pathways in the lungs. This approach could potentially reduce the frequency and severity of exacerbations. Researchers are excited about BI 1291583 because it represents a novel mechanism of action that might offer more effective, targeted relief for patients, potentially improving their quality of life significantly.
What evidence suggests that BI 1291583 might be an effective treatment for bronchiectasis?
Research has shown that BI 1291583, which participants in this trial may receive, can help lower the risk of flare-ups in adults with bronchiectasis. It blocks a substance called cathepsin C, which contributes to lung inflammation. In studies, people who took BI 1291583 experienced fewer flare-ups compared to those who took a placebo. This medicine has shown promise in improving symptoms and quality of life for people with bronchiectasis. Overall, evidence suggests that BI 1291583 could effectively treat this condition.56789
Are You a Good Fit for This Trial?
Adults with bronchiectasis who produce sputum and have had at least 2 flare-ups or 1 flare-up with significant symptoms can join. They must consent to the study, use effective birth control if applicable, and have a CT-confirmed diagnosis. Those on certain chronic treatments need at least one recent exacerbation.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take 1 tablet once a day for up to 1 year and 6 months. The study involves up to 10 site visits and about 13 phone calls. Participants complete a daily diary on a smartphone about their bronchiectasis symptoms.
Follow-up
Participants are monitored for safety and effectiveness after treatment. The study doctors regularly check participants' health and take note of any unwanted effects.
What Are the Treatments Tested in This Trial?
Interventions
- BI 1291583
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor