Trial reportJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2014
A randomized double blind, placebo controlled phase 2 trial of BIIL 284 BS (an LTB4 receptor antagonist) for the treatment of lung disease in children and adults with cystic fibrosis.
Trial report in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 1 of them a synthesis 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
65 citing papers in PubMed, 1 synthesis or guideline pooled it, 133 citations in OpenAlex.
- Long-acting inhaled bronchodilators for cystic fibrosis.The Cochrane database of systematic reviews · 2017Pooled it
- Empire-CF study: A phase 2 clinical trial of leukotriene A4 hydrolase inhibitor acebilustat in adult subjects with cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021Trial
- Phase I Studies of Acebilustat: Biomarker Response and Safety in Patients with Cystic Fibrosis.Clinical and translational science · 2017Trial
- Phase III AIRTIVITY study design: verducatib (BI 1291583) in people with bronchiectasis.ERJ open research · 2026Article
- Dual host and pathogen targeting by MEK1/2 inhibitors.Infection and immunity · 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
- Bronchiectasis Treatment Goals, Unmet Needs, and Emerging Therapies: A Podcast.Pulmonary therapy · 2026Article
- Brensocatib-Another Therapeutic "Window of Opportunity" for Patients with Bronchiectasis.Journal of clinical medicine · 2026Review
- Making real progress in the world of bronchiectasis.Journal of thoracic disease · 2025Article
- Pulmonary Emphysema: Current Understanding of Disease Pathogenesis and Therapeutic Approaches.Biomedicines · 2025Review
- CCR2+ monocytes are dispensable to resolve acute pulmonary Pseudomonas aeruginosa infections in WT and cystic fibrosis mice.Journal of leukocyte biology · 2025Article
- How Effectively Can Oxidative Stress and Inflammation Be Reversed When CFTR Function Is Pharmacologically Improved?Antioxidants (Basel, Switzerland) · 2025Review
- Targeting neutrophil serine proteases in bronchiectasis.The European respiratory journal · 2025Review
- Preclinical murine models for the testing of antimicrobials against Mycobacterium abscessus pulmonary infections: Current practices and recommendations.Tuberculosis (Edinburgh, Scotland) · 2024Review
- Neutrophil Extracellular Traps and Respiratory Disease.Journal of clinical medicine · 2024Review
- MEK1/2 inhibition decreases pro-inflammatory responses in macrophages from people with cystic fibrosis and mitigates severity of illness in experimental murine methicillin-resistantFrontiers in cellular and infection microbiology · 2024Article
- Article
- Diagnosis and Management of Cystic Fibrosis Exacerbations.Seminars in respiratory and critical care medicine · 2023Review
- Recruited monocytes/macrophages drive pulmonary neutrophilic inflammation and irreversible lung tissue remodeling in cystic fibrosis.Cell reports · 2022Article
- Pathogenesis of pneumonia and acute lung injury.Clinical science (London, England : 1979) · 2022Review
5 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors at 8 institutions in 3 countries.
Funding
Abstract
backgroundAirway inflammation, mediated in part by LTB4, contributes to lung destruction in patients with cystic fibrosis (CF). LTB(4)-receptor inhibition may reduce airway inflammation. We report the results of a randomized, double-blind, placebo-controlled study of the efficacy and safety of the leukotriene B(4) (LTB(4))-receptor antagonist BIIL 284 BS in CF patients.
methodsCF patients aged ≥6 years with mild to moderate lung disease were randomized to oral BIIL 284 BS or placebo once daily for 24 weeks. Co-primary endpoints were change in FEV(1) and incidence of pulmonary exacerbation.
resultsAfter 420 (155 children, 265 adults) of the planned 600 patients were randomized, the trial was terminated after a planned interim analysis revealed a significant increase in pulmonary related serious adverse events (SAEs) in adults receiving BIIL 284 BS. Final analysis revealed SAEs in 36.1% of adults receiving BIIL 284 BS vs. 21.2% receiving placebo (p = 0.007), and in 29.6% of children receiving BIIL 284 BS vs. 22.9% receiving placebo (p = 0.348). In adults, the incidence of protocol-defined pulmonary exacerbation was greater in those receiving BIIL 284 BS than in those receiving placebo (33.1% vs. 18.2% respectively; p = 0.005). In children, the incidence of protocol-defined pulmonary exacerbation was 19.8% in the BIIL 284 BS arm, and 25.7% in the placebo arm (p = 0.38).
conclusionsWhile the cause of increased SAEs and exacerbations due to BIIL 284 BS is unknown, the outcome of this trial provides a cautionary tale for the administration of potent anti-inflammatory compounds to individuals with chronic infections, as the potential to significantly suppress the inflammatory response may increase the risk of infection-related adverse events.
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Registered trials
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 OpenQuestion graph.