Effect and safety of roflumilast for chronic obstructive pulmonary disease in Chinese patients.

BACKGROUND

This trial aimed to evaluate the efficacy and safety of roflumilast for treating Chinese patients with chronic obstructive pulmonary disease (COPD).

METHODS

A total of 120 patients with COPD were recruited and were randomly divided into 2 groups (an intervention group and a placebo group) at a 1:1 ratio. Patients received either roflumilast or placebo 500 μg once daily for a total of 12 months. The primary outcome was lung function, measured by the change from baseline of forced expiratory volume in 1 second (FEV1), FVC = forced vital capacity (FVC), and FEF25-75%. The secondary outcome measurements included the quality of life, measured with the St. George's Respiratory Questionnaire (SGRQ). All outcomes were measured at the end of 12-month treatment and 3-month follow-up after the treatment. In addition, adverse events (AEs) were also recorded during the treatment period.

RESULTS

FEV1, FVC, FEF25-75%, and SGRQ were significantly better in the intervention group than those in the placebo group at the end of 12-month treatment and 3-month follow up after treatment. Moreover, AEs were much higher with roflumilast than placebo in this study.

CONCLUSIONS

The findings suggest that roflumilast has promising effect to improve lung function in Chinese population with COPD.