Abstract:
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.
journal_name
Medicine (Baltimore)journal_title
Medicineauthors
Liu DY,Wang ZG,Gao Y,Zhang HM,Zhang YX,Wang XJ,Peng Ddoi
10.1097/MD.0000000000009864subject
Has Abstractpub_date
2018-02-01 00:00:00pages
e9864issue
7eissn
0025-7974issn
1536-5964pii
00005792-201802160-00024journal_volume
97pub_type
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