Effects of Roflumilast on Exacerbations and Lung Function in COPD Patients with Bronchiectasis

Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, reduces neutrophilic airway inflammation and exacerbations in chronic obstructive pulmonary disease (COPD). However, the effect of coexisting bronchiectasis on its efficacy remains unclear. This study evaluates the long-term impact of roflumilast use in this population. A retrospective cohort study was conducted using data from 2,181 COPD patients. Of them, 180 had bronchiectasis confirmed on CT, with 162 not using roflumilast and 18 receiving it. Baseline data, including demographics, symptom scores, pulmonary function, and biomarkers, were collected. Patients were followed for one year to assess exacerbations and mortality, and survivors were monitored for up to three years for symptom and pulmonary function changes. Multivariate logistic regression was performed to determine predictors of exacerbations. Moderate and severe exacerbations occurred more frequently in the roflumilast group, but mortality did not differ between groups. Roflumilast users showed significant improvements in post-bronchodilator forced expiratory volume in one second (FEV₁) (p=0.028), as well as in the ratio of forced expiratory volume in one second to the forced vital capacity (FEV₁/FVC) ratio (p=0.015) compared to no roflumilast group. In multivariate analysis, roflumilast use was independently associated with a higher exacerbation risk (p=0.004, OR=14.643, 95% CI: 2.36-90.848). While roflumilast improved pulmonary function and symptoms in COPD patients with bronchiectasis, it was also linked to a higher risk of exacerbations. These findings suggest caution in its use for this population, and further randomized controlled trials are needed to assess its safety and efficacy.