Trial reportThe European respiratory journal2025
Cathepsin C (dipeptidyl peptidase 1) inhibition in adults with bronchiectasis: AIRLEAF, a phase II randomised, double-blind, placebo-controlled, dose-finding study.
Trial report in The European respiratory journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The European respiratory society guideline for adult bronchiectasis 2025: summary and implementation guide for primary care.NPJ primary care respiratory medicine · 2026Guideline
- Efficacy and safety of DPP-1 inhibitors in bronchiectasis: a GRADE-assessed meta-analysis of randomized controlled trials.Respiratory research · 2025Pooled it
- Endotypes ofAmerican journal of respiratory and critical care medicine · 2025Trial
- Efficacy and Safety of Brensocatib in Participants of Asian Race with Non-cystic Fibrosis Bronchiectasis: A Subgroup Analysis of the ASPEN Trial.Pulmonary therapy · 2026Article
- Age-Specific Considerations in Bronchiectasis Management: Focus on Older Adults with Emphasis on Anti-inflammatory Treatment.Drugs & aging · 2026Review
- The frequent exacerbator phenotype in bronchiectasis revisited: data from EMBARC registry.American journal of respiratory and critical care medicine · 2026Article
- Florensocatib in adults with bronchiectasis: the HOPE-BE trial protocol and baseline demographic characteristics.ERJ open research · 2026Article
- Pulmonary Exacerbations and Treatment in PCD: A Narrative Review.Pediatric pulmonology · 2026Review
- Patient-reported outcome measures developed for non-cystic fibrosis bronchiectasis may be applied to cystic fibrosis bronchiectasis.Health and quality of life outcomes · 2026Article
- Regenerative therapeutics for chronic obstructive pulmonary disease.Pharmacological reviews · 2026Review
- Lower airway dysbiosis in nontuberculous mycobacteria-positive bronchiectasis is associated with neutrophil extracellular trap-predominant severe phenotypes.American journal of respiratory and critical care medicine · 2026Article
- The Role of Dipeptidyl Peptidase Inhibitors in Pulmonary Diseases.Biomedicines · 2026Review
- The importance of symptoms in bronchiectasis.European respiratory review : an official journal of the European Respiratory Society · 2026Review
- The European Respiratory Society guideline for management of adult bronchiectasis: clinical summary.Breathe (Sheffield, England) · 2026Review
- Fungal-Associated Endotypes as a Treatable Trait in Bronchiectasis.Pulmonary therapy · 2026Review
- Article
- Bronchiectasis Treatment Goals, Unmet Needs, and Emerging Therapies: A Podcast.Pulmonary therapy · 2026Article
- Changes in sputum viscoelastic properties and airway inflammation in primary ciliary dyskinesia are comparable to cystic fibrosis on elexacaftor/tezacaftor/ivacaftor therapy.The European respiratory journal · 2026Article
- The convergent pathway of obstructive lung disease: the disease-modifying potential of dipeptidyl peptidase 1 inhibition in COPD, asthma and bronchiectasis overlap.Drugs in context · 2026Review
- Advanced Lung Cancer Inflammation Index (ALI) as an Independent Predictor for Bronchiectasis Exacerbation Risks.Journal of inflammation research · 2026Article
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBronchiectasis is characterised by uncontrolled neutrophil serine protease (NSP) activity. Cathepsin C (CatC; dipeptidyl peptidase 1) activates NSPs during neutrophil maturation. CatC inhibitors can potentially reduce neutrophil-mediated lung damage. This phase II, randomised, double-blind, placebo-controlled trial (AIRLEAF
methodsIn total, 322 participants were randomised (2:1:1:2) to receive one of three oral doses of BI 1291583 (1 mg/2.5 mg/5 mg) or placebo for 24-48 weeks. A multiple comparison procedure and modelling approach was used to demonstrate a nonflat dose-response curve based on the time to first pulmonary exacerbation up to week 48. In addition, efficacy of individual BI 1291583 doses was evaluated based on the frequency of exacerbations, severe exacerbations (fatal or leading to hospitalisation and/or intravenous antibiotic administration), lung function and quality of life.
resultsA significant dose-dependent benefit of BI 1291583 over placebo was established based on time to first exacerbation (shape: maximum effect curve 1; adjusted p=0.0448). Treatment with BI 1291583 5 mg and 2.5 mg numerically reduced the risk of an exacerbation compared with placebo (hazard ratio (95% CI) 0.71 (0.48 to 1.05) and 0.66 (0.40 to 1.08), respectively; both p>0.05). BI 1291583 2.5 mg showed numerically better efficacy compared with 5 mg across several end-points; 1 mg was similar to placebo. The safety profile of BI 1291583 was similar to placebo.
conclusionTreatment with BI 1291583 resulted in a reduction in the risk of experiencing an exacerbation in adults with bronchiectasis.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.