A pilot study to assess the role of 12-week roflumilast treatment in non-CF bronchiectasis

BACKGROUND: Roflumilast demonstrated anti-inflammatory activity in COPD. While bronchiectasis is also characterised by neutrophilic inflammation, there is a lack of evidence on the use of roflumilast in bronchiectasis. METHODS: An open‑label observation study with an exploratory nature was conducted in Hong Kong. The primary outcome measure was 24-hour sputum volume. The extent of airway inflammation was indicated by sputum leucocyte density, pro-inflammatory cytokines and neutrophil elastase. All eligible patients were treated with roflumilast, starting at 250 µg daily with possible escalation to 500 µg daily if tolerated. RESULTS: A total of 39 patients were started on roflumilast with 24 (61.5%) completed 12 weeks of treatment and 9 of them escalated to 500 µg daily. There were no significant changes in mean daily sputum volume. The median sputum leucocyte density and TNF-α significantly decreased from the recruitment visit to 12 weeks. In extrapolatory analyses, patients with a baseline daily sputum volume ≥ 20 mL might be more likely to respond with a reduction in sputum volume. CONCLUSION: Roflumilast treatment in non-CF bronchiectasis could provide anti-inflammatory effects with a significant reduction in sputum leucocyte density and TNF-α level over 12 weeks of treatment. Extrapolatory analyses suggested potential benefits in sputum volume reduction among the subgroup with baseline daily sputum volume ≥ 20 mL.