Roflumilast for the treatment of respiratory disease: review of the Phase II and III trials

Roflumilast (Daxas® [EU], Daliresp® [USA]) is the first phospho diesterase 4 inhib itor approved in Europe to be used in severe chronic obstructive pulmonary disease (COPD). Its preclinical evaluation streamed its subsequent clinical development towards COPD based on the prominent anti-inflammatory activities demonstrated in various preclinical models of COPD. Its clinical development was based mainly on Phase III studies initially performed in COPD patients with various stages of disease severity and then focused on severe COPD patients with chronic bronchitis. On both a shortand long-term basis, roflumilast was demonstrated to reduce the incidence of moderate to severe COPD exacerbations and to improve lung function. This article discusses the clinical relevance of the data coming from Phase II and III studies and raises some issues related to the use of roflumilast in COPD.