NICE has issued final guidance (TA 244) on roflumilast for the management of severe chronic obstructive pulmonary disease (COPD), which contains the following recommendations:

• Roflumilast is recommended only in the context of research as part of a clinical trial for adults with severe COPD (defined as forced expiratory volume in 1 second [FEV1] post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of frequent exacerbations as an add-on to bronchodilator treatment.

• Such research should be designed to generate robust evidence about the benefits of roflumilast as an add-on to long-acting muscarinic antagonists (LAMA) plus long-acting beta2 agonists (LABA) plus inhaled corticosteroids (ICS), or LAMA plus LABA for people who are intolerant to ICS.

• People receiving roflumilast should have the option to continue treatment until they and their clinicians consider it appropriate to stop.