BI 1291583 for Bronchiectasis

Recruiting at 135 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Antifungals, Antituberculars, Antivirals, others

Disqualifiers: Cystic fibrosis, Liver disease, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 24-52 weeks

322 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it mentions that patients who must continue taking restricted medications or any drug likely to interfere with the trial may be excluded. It's best to discuss your specific medications with the trial team.

What makes the drug BI 1291583 unique for treating bronchiectasis?

BI 1291583 is unique because it is an oral drug that inhibits cathepsin C, which may reduce airway inflammation and prevent further damage by decreasing the activation of certain enzymes in the lungs. This approach is different from other treatments like bronchodilators or inhaled corticosteroids, which focus on opening airways or reducing inflammation through different mechanisms. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I will use contraception if my partner can become pregnant.

I am using highly effective birth control and one barrier method.

I have signed and understand the consent form for this study.

Exclusion Criteria

You have another serious health condition that could be made worse by taking part in the study.

You have certain medical conditions, such as cystic fibrosis, immune system disorders, skin conditions, or infections, that would prevent you from participating in the trial.

I have severe gum disease or teeth issues that could cause pain or need extraction.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of BI 1291583 or placebo for 6 months to 1 year

24-52 weeks

10 visits (in-person), 5 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 1291583
• Placebo

Trial Overview 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.

Participant Groups

Group I: BI 1291583: Medium dose group Experimental Treatment 1 Intervention

Group II: BI 1291583: Low dose group Experimental Treatment 1 Intervention

Group III: BI 1291583: High dose group Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Findings from Research

In a double-blind, placebo-controlled study of 24 patients with bronchiectasis, inhaled fluticasone significantly reduced inflammatory markers in sputum, including leukocyte density and interleukin levels, indicating its efficacy in managing inflammation associated with the condition.

The treatment group experienced fewer exacerbations (1 episode) compared to the placebo group (3 episodes), and there were no significant changes in lung function or adverse reactions, suggesting that fluticasone is safe for use in bronchiectasis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled fluticasone reduces sputum inflammatory indices in severe bronchiectasis. Tsang, KW., Ho, PL., Lam, WK., et al.[2015]

Bronchiectasis (BE) is a growing global health issue characterized by airway dilation and persistent infections, leading to significant impacts on patients' quality of life, yet treatment guidelines are based on limited high-quality evidence.

Experts identified critical unmet needs in BE management, including the need for better pharmacological treatments to clear airways and reduce inflammation, improved methods for classifying patients, and the establishment of clinical endpoints for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards development of evidence to inform recommendations for the evaluation and management of bronchiectasis. Flume, PA., Basavaraj, A., Garcia, B., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

A Phase 2 randomised study to establish efficacy, safety and dosing of a novel oral cathepsin C inhibitor, BI 1291583, in adults with bronchiectasis: Airleaf. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Dual bronchodilators in Bronchiectasis study (DIBS): protocol for a pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, randomised controlled trial studying bronchodilators in preventing exacerbations of bronchiectasis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The generalizability of bronchiectasis randomized controlled trials: A multicentre cohort study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Inhaled fluticasone reduces sputum inflammatory indices in severe bronchiectasis. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Towards development of evidence to inform recommendations for the evaluation and management of bronchiectasis. [2023]