Roflumilast, a FDA–approved, once–daily, oral, selective phosphodiesterase–4 inhibitor, has been shown to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Exacerbations (flare–ups) of moderate or severe severity may require alterations in treatment and can cause hospitalization for patients, which may then affect their quality of life. The purpose of this study was to investigate the effect of roflumilast treatment on health–related quality of life (HRQoL) in COPD patients, particularly COPD patients with a history of exacerbations.
Data is from Study M2–111 (OPUS), a 52–week randomized, double–blind, placebo–controlled, multicenter, parallel group phase 3 clinical trial of roflumilast 500 mg once daily in patients with COPD. The St George’s Respiratory Questionnaire (SGRQ) was used to measure HRQoL. For SGRQ, a change of =4 units is generally accepted as a minimal clinically important difference. A post hoc analysis was performed on the overall patient population, subpopulation with a history of exacerbations, and subpopulation with chronic bronchitis. In each treatment group, the number and proportion of patients who improved =4 units on the SGRQ total score at Week 52 (last observation carried forward) were calculated and compared using chi–square test.
A total of 1,173 COPD patients were enrolled in the trial: 567 in the roflumilast group and 606 in the placebo group. The proportion of patients with improvements in SGRQ total score of =4 units was greater in the roflumilast group than in the placebo group in the overall population (36.38% vs. 33.39%, P=0.3078) and subpopulation with chronic bronchitis (36.72% vs. 34.02%, P=0.4630), though these differences did not achieve statistical significance. In the subgroup of patients with a history of exacerbations (821 patients: 389 in the roflumilast group and 432 in the placebo group), the proportion of patients with =4 unit improvement in SGRQ total score was 38.56% in the roflumilast group and 31.71% in the placebo group (P=0.0399), indicating a relative improvement of 21.60% for patients in the roflumilast group.
Analysis of this clinical trial data suggests that roflumilast provides a clinically meaningful and statistically significant improvement in HRQoL in COPD patients with a history of exacerbations.