What side effects are associated with this type of intervention?

Common treatments for bronchiectasis include antibiotics, mucolytics, and anti-inflammatory agents. Antibiotics, which are often used to manage infections, can cause side effects such as gastrointestinal upset, allergic reactions, and antibiotic resistance. Mucolytics, which help to thin mucus, may lead to nausea, vomiting, and, in some cases, bronchospasm. Anti-inflammatory agents, including corticosteroids, can result in side effects like weight gain, osteoporosis, and increased risk of infections. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for bronchiectasis, primarily focusing on managing symptoms and preventing exacerbations. Commonly used treatments include antibiotics like tobramycin and aztreonam, which target chronic pulmonary infections, and mucolytics such as N-acetylcysteine to help clear mucus. Bronchodilators, including tiotropium, are also used to improve airflow. These treatments aim to reduce the frequency of flare-ups and improve the quality of life for patients with bronchiectasis.

What other types of research exist?

Promising novel alternatives to BI 1291583 for Bronchiectasis patients include: 1) Nintedanib, an antifibrotic agent that has shown efficacy in slowing lung function decline in various interstitial lung diseases, which may have potential benefits in bronchiectasis. 2) Azole antifungals, such as those studied for cystic fibrosis, which may help manage chronic pulmonary infections in bronchiectasis. 3) Hypertonic saline inhalation, which has been effective in improving mucociliary clearance in cystic fibrosis and could be beneficial for bronchiectasis patients. 4) Bronchodilators like glycopyrrolate, which have shown efficacy in COPD and may help improve airflow in bronchiectasis patients.

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Unknown

BI 1291583 for Bronchiectasis

Phase 2

Waitlist Available

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP.

History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either: at least 2 exacerbations, or at least 1 exacerbation and a St. George´s Respiratory Questionnaire (SGRQ) Symptoms score of >40 at screening visit 1.

Must not have

Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) >3.0 x upper limit of normal (ULN) at Visit 1, or moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment).

Received any live attenuated vaccine within 4 weeks prior to Visit 2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests if BI 1291583 can help adults with bronchiectasis who often have flare-ups. Participants take the medicine regularly, and doctors compare the time to the first flare-up between those on the medicine and those not taking it.

Who is the study for?

Adults aged 18-85 with bronchiectasis, who produce sputum and have had flare-ups requiring antibiotics can join this study. They must use effective contraception if of childbearing potential. Excluded are those with certain other diseases like Cystic Fibrosis or immune deficiencies, severe liver disease, recent infections, or uncontrolled medical conditions.

What is being tested?

The trial is testing the effectiveness of BI 1291583 in different doses compared to a placebo for treating bronchiectasis. Participants will be randomly assigned to one of four groups and take tablets daily for 6 months to a year while their health and flare-up frequency are monitored.

What are the potential side effects?

While specific side effects aren't listed here, participants' health will be closely watched for any unwanted effects from BI 1291583 or the placebo during visits and phone calls throughout the study period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will use contraception if my partner can become pregnant.

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I've needed antibiotics for lung problems at least twice last year or once with a high symptoms score.

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I have been diagnosed with bronchiectasis and have symptoms like coughing and frequent infections.

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I can produce sputum naturally and have a history of chronic coughing up of mucus.

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I've had at least one lung infection flare-up since starting my long-term antibiotics.

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I am between 18 and 85 years old (19 in Korea).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver tests are high or I have moderate to severe liver disease.

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I have not received a live vaccine in the last 4 weeks.

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My kidney function is very low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 1291583: Medium dose groupExperimental Treatment1 Intervention

Group II: BI 1291583: Low dose groupExperimental Treatment1 Intervention

Group III: BI 1291583: High dose groupExperimental Treatment1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 1291583

2019

Completed Phase 2

~450

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Bronchiectasis include antibiotics, which target bacterial infections that exacerbate the condition, and mucolytics, which help to thin and clear mucus from the airways. Anti-inflammatory agents are also used to reduce inflammation in the bronchial walls. These treatments are crucial for Bronchiectasis patients as they help manage symptoms, reduce the frequency of exacerbations, and improve overall lung function. The trial of BI 1291583 aims to explore a new medication that could potentially reduce flare-ups, which is significant as frequent exacerbations can lead to further lung damage and decreased quality of life.

Anticholinergic therapy for bronchiectasis.