1 Guidance

1 Guidance

1.1 Roflumilast is recommended only in the context of research as part of a clinical trial for adults with severe chronic obstructive pulmonary disease (COPD) (for the purposes of this guidance 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.

1.2 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.

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

  • National Institute for Health and Care Excellence (NICE)