Chronic obstructive pulmonary disease (COPD) is a progressive inflammatory airway disease. To date, limited effective treatments are available that target the underlying disease pathophysiology of inflammation. Roflumilast is an oral, once-daily phosphodiesterase 4 (PDE4) inhibitor with demonstrated anti-inflammatory activity. This study compared the efficacy of roflumilast 250 μg and 500 μg against placebo in patients with moderate-to-severe COPD.
This was a double-blind, randomized, placebo-controlled, multinational, multicenter study. After a 4-week run-in period, 1411 patients with forced expiratory volume in 1 second (FEV1) of 30% to 80% of predicted and post-salbutamol reversibility of < 12% and/or < 200 mL were treated with oral roflumilast 250 μg (N = 576) or 500 μg (N = 555), or placebo (N = 280) once daily for 24 weeks. Lung function and health-related quality of life were assessed by spirometry and the St. George’s Respiratory Questionnaire (SGRQ), respectively.
After 24 weeks of treatment, post-salbutamol FEV1 increased from baseline with roflumilast 250 μg and 500 μg (29 mL and 51 mL, respectively; p < 0.0134). In contrast, the placebo group experienced a decline in FEV1 (-45 mL; p = 0.0041) as the disease progressed over the course of the investigation. At study end, differences in FEV1 between roflumilast 250 μg and 500 μg, and placebo were 74 mL and 97 mL, respectively (p<0.0001 for both doses). FEV6 also improved with roflumilast 250 μg and 500 μg (95 mL and 135 mL, respectively; p < 0.0001) as compared with placebo. Change in SGRQ total score was greater with roflumilast 250 μg and 500 μg (3.35 and 3.51 unit decrease, respectively) as compared with placebo (1.79 unit decrease).
Oral, once-daily roflumilast significantly improved lung function and health-related quality of life in patients with moderate-to-severe COPD.
Roflumilast, a new class of anti-inflammatory agent may prove useful in COPD therapy.
K.F. Rabe, None.