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Randomized Controlled Trial
. 2018 Feb;97(7):e9864.
doi: 10.1097/MD.0000000000009864.

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

Dong-Yang Liu  1 , Zhi-Guo Wang, Yuan Gao, Hui-Min Zhang, Yu-Xiang Zhang, Xiao-Jun Wang, Dan Peng
Affiliations
Randomized Controlled Trial

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

Dong-Yang Liu et al. Medicine (Baltimore). 2018 Feb.

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.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Flowchart of participants throughout the study selection.
See this image and copyright information in PMC

References

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