Efficacy and safety of roflumilast in bronchiectasis patients: a cross-over, double-blinded placebo-controlled trial

Management of bronchiectasis is a challenge, with few therapeutic options. Roflumilast is a phosphodiestese-4 inhibitor with anti-inflammatory actions that reduces exacerbations and improves lung function in COPD. Similar result might be seen in bronchiectasis since they share similar inflammatory profile. <bold>Objective:</bold> evaluate efficacy and safety of roflumilast in patients with bronchiectasis. Primary outcome: quality of life measured by Saint George Respiratory Questionnaire (SGRQ). A cross-over, double-blinded, placebo-controlled clinical trial of a bronchiectasis non-cystic fibrosis outpatient clinic, randomized into two groups: started taking placebo or roflumilast for 12 weeks of follow-up with a 2-week washout interval in between. 30 patients evaluated, 23 completed. No statistically difference was observed in quality of life measured by SGRQ. In the quality of life bronchiectasis (QOL-B) questionnaire, there was an improvement of 9 points in social domain, statistically significant. There was no difference in others domains of QOL-B nor in others questionnaires measured (BHQ, LCQ and CAT). We observed an improvement of 130mL in FVC during roflumilast phase, no difference was observed in FEV1. The mean levels of MUC5 in sputum was reduced by roflumilast (−268pg/mL vs +102pg/mL). No difference was observed on systemic inflammatory markers (CRP and fibrinogen). Roflumilast was well tolerated, side effects were mostly mild. We could not demonstrate a positive impact of roflumilast on quality of life. Findings regarding the anti-inflammatory effect on mucus were observed through reduction of MUC5 levels in sputum, which may justify improvement on FVC observed.