Roflumilast for treating chronic obstructive pulmonary disease – guidance (TA461)

Roflumilast is recommended as an add-on to bronchodilator therapy for treating severe chronic obstructive pulmonary disease in adults with chronic bronchitis providing certain criteria are met.

These criteria include the following: 

• disease is severe, defined as a forced expiratory volume in 1 second (FEV1) after a bronchodilator of less than 50% of predicted normal, and
• patient has had two or more exacerbations in the previous 12 months despite triple inhaled therapy with a long-acting muscarinic antagonist, a long-acting beta-2 agonist and an inhaled corticosteroid.