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Anti-inflammatory agent
BI 1291583 for Bronchiectasis
Phase 2
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment) or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3.0x Upper limit of normal (ULN) at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then)
Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula <30 mL/min at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Summary
This trial evaluates if a medicine (BI 1291583) helps adults with bronchiectasis. Participants take the medicine daily for up to a year & visit study site 9 times. Doctors check if medicine helps reduce symptoms.
Who is the study for?
Adults with bronchiectasis who previously participated in the Airleafᵀᴹ study can join this trial. They must consent to the study, be able to use effective birth control methods if applicable, and have completed prior treatment as per protocol. People with certain infections, liver disease, recent vaccinations or infections, or specific medical conditions are excluded.
What is being tested?
The trial is testing BI 1291583's long-term effects on bronchiectasis symptoms. Participants will take a low, medium, or high dose of BI 1291583 daily for up to a year. Some participants will receive a placebo instead. The study involves nine site visits and four phone calls to monitor health outcomes.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include typical drug reactions such as gastrointestinal issues (nausea/vomiting), headaches, dizziness or allergic reactions due to long-term medication intake.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have moderate to severe liver disease or my liver tests are more than three times the normal limit.
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My kidney function is very low, with an eGFR below 30 mL/min.
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I have been newly diagnosed with low immune proteins.
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I have been newly diagnosed with common variable immunodeficiency.
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I am newly diagnosed with α1-antitrypsin deficiency and am receiving augmentation therapy.
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I have been newly diagnosed with a lung condition due to a fungal infection and need treatment.
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I am being treated for a new tuberculosis or similar infection.
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I have been newly diagnosed with a skin condition on my palms or soles.
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I have been newly diagnosed with psoriasis on my palms and soles, or it covers 10% or more of my body.
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I have been newly diagnosed with reactive arthritis or keratoderma blennorrhagicum.
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I have been newly diagnosed with pityriasis rubra pilaris.
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I have a new diagnosis of eczema on my hands and feet or it covers 10% or more of my body.
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I haven't had a serious lung infection in the last 4 weeks.
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I haven't taken any antibiotics or antifungal medications in the last 4 weeks.
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I have not had a live vaccine in the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of treatment-emergent adverse events (TEAEs)
Secondary study objectives
Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial
Time to first pulmonary exacerbation from first drug administration in this trial to the end of the trial
Trial Design
3Treatment groups
Experimental Treatment
Group I: BI 1291583 medium dose armExperimental Treatment2 Interventions
Group II: BI 1291583 low dose armExperimental Treatment2 Interventions
Group III: BI 1291583 high dose armExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1291583
2024
Completed Phase 2
~450
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,769,073 Total Patients Enrolled
3 Trials studying Bronchiectasis
351 Patients Enrolled for Bronchiectasis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a positive test for hepatitis B, hepatitis C, or HIV. If these test results change after you join the study, you may not be able to continue participating.I have been newly diagnosed with extensive warts.I have been newly diagnosed with a lung condition due to a fungal infection and need treatment.I have been newly diagnosed with a skin condition on my palms or soles.I have been newly diagnosed with low immune proteins.I haven't had a serious lung infection in the last 4 weeks.I have been newly diagnosed with common variable immunodeficiency.I am newly diagnosed with α1-antitrypsin deficiency and am receiving augmentation therapy.My kidney function is very low, with an eGFR below 30 mL/min.I have signed and understand the consent form for this trial.I have moderate to severe liver disease or my liver tests are more than three times the normal limit.I have not had a live vaccine in the last 4 weeks.I am being treated for a new tuberculosis or similar infection.I am either male or female.I have been newly diagnosed with reactive arthritis or keratoderma blennorrhagicum.Your blood neutrophil count is less than 1,000 cells per microliter.I have a new diagnosis of hypothyroidism or related conditions, or my hypothyroidism is under control with treatment.I have a fungal infection on my hand or feet that hasn't improved with treatment.I have been newly diagnosed with pityriasis rubra pilaris.You finished the treatment as planned in a previous study.I have a new diagnosis of eczema on my hands and feet or it covers 10% or more of my body.I have been newly diagnosed with psoriasis on my palms and soles, or it covers 10% or more of my body.I haven't taken any antibiotics or antifungal medications in the last 4 weeks.You have a medical condition that could make participating in the trial risky, such as certain immune system disorders or other serious health issues.
Research Study Groups:
This trial has the following groups:- Group 1: BI 1291583 high dose arm
- Group 2: BI 1291583 low dose arm
- Group 3: BI 1291583 medium dose arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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