NCT05238675

A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis

Completed Phase 2 Last updated 14 August 2025

What this trial tests

Phase 2 trial testing BI 1291583 in Bronchiectasis in 322 participants. Completed in 30 May 2024.

Timeline

28 April 2022

Primary endpoint
1 May 2024

30 May 2024

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	322
Start date	28 April 2022
Primary completion	1 May 2024
Estimated completion	30 May 2024
Sites	112 locations across Italy, Japan, Poland, South Korea, Denmark, Netherlands, Belgium, Mexico

Drugs / interventions tested

• BI 1291583 — full drug profile →
• Placebo

Conditions studied

• Bronchiectasis — all drugs for Bronchiectasis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 85, any sex, with Bronchiectasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations).

The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis.

Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day.

Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff.

The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cathepsin C (dipeptidyl peptidase 1) inhibition in adults with bronchiectasis: AIRLEAF, a phase II randomised, double-blind, placebo-controlled, dose-finding study.
   Chalmers JD, Shteinberg M, Mall MA, O'Donnell AE, et al · · 2025 · cited 43× · PMID 39255990 · DOI 10.1183/13993003.01551-2024
2. Dipeptidyl peptidase 1 inhibition as a potential therapeutic approach in neutrophil-mediated inflammatory disease.
   Chalmers JD, Kettritz R, Korkmaz B. · · 2023 · cited 32× · PMID 38162644 · DOI 10.3389/fimmu.2023.1239151
3. 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.
   Chalmers JD, Gupta A, Chotirmall SH, Armstrong A, et al · · 2023 · cited 31× · PMID 37465817 · DOI 10.1183/23120541.00633-2022
4. Neutrophilic inflammation in bronchiectasis.
   Chalmers JD, Metersky M, Aliberti S, Morgan L, et al · · 2025 · cited 16× · PMID 40174958 · DOI 10.1183/16000617.0179-2024
5. Novel cathepsin C inhibitor, BI 1291583, intended for treatment of bronchiectasis: Phase I characterization in healthy volunteers.
   Badorrek P, Diefenbach C, Kögler H, Eleftheraki A, et al · · 2024 · cited 8× · PMID 39175217 · DOI 10.1111/cts.13891
6. Pharmacological inhibition of the cysteine protease cathepsin C improves graft function after heart transplantation in rats.
   Liu B, Korkmaz B, Kraft P, Mayer T, et al · · 2023 · cited 6× · PMID 37946197 · DOI 10.1186/s12967-023-04659-6
7. Dipeptidyl peptidase-1 inhibitors in bronchiectasis.
   Johnson E, Gilmour A, Chalmers JD. · · 2025 · cited 5× · PMID 40533102 · DOI 10.1183/16000617.0257-2024
8. A randomized phase I study of the safety and pharmacokinetics of BI 1291583 in healthy Japanese male subjects.
   Tadayasu Y, Sarubbi D, Furuichi T, Eleftheraki A, et al · · 2025 · cited 3× · PMID 39299301 · DOI 10.1111/bcp.16249