Effect of Roflumilast and Inhaled Corticosteroid/Long-Acting β ₂ -Agonist on Chronic Obstructive Pulmonary Disease Exacerbations (RE ² SPOND). A Randomized Clinical Trial

Abstract

Roflumilast failed to statistically significantly reduce moderate and/or severe exacerbations in the overall population. Roflumilast improved lung function and reduced exacerbations in participants with frequent exacerbations and/or hospitalization history. The safety profile of roflumilast was consistent with that of previous studies. Clinical trial registered with www.clinicaltrials.gov (NCT01443845).