Few studies of the efficacy and safety of therapy with combinations of salmeterol/fluticasone
propionate (SFCs) have been conducted in Chinese patients with COPD, and the benefits
of combination therapy in nonsmoking patients with COPD are, to our knowledge, not
known.
The aims were to establish the efficacy and tolerability of the therapy with SFC (salmeterol,
50 microg/fluticasone, 500 microg, twice daily) in the management of Chinese COPD
patients and to investigate the effectiveness of SFC in nonsmokers with COPD.
This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter
study. Changes in prebronchodilator and postbronchodilator FEV(1), quality of life
determined by the St. George Respiratory Questionnaire (SGRQ) scores, relief bronchodilator
use, nighttime awakenings, and frequency of exacerbations of COPD were measured in
patients randomized to receive SFC (n = 297) or placebo (n = 148). Never-smokers,
former smokers, and current smokers accounted for 11.7%, 66.7%, and 21.6%, respectively,
of the study population.
After 24 weeks, the mean changes in prebronchodilator and postbronchodilator FEV(1)
were 180 mL (95% confidence interval [CI], approximately 91 to 268; p < 0.001) and
65 mL (95% CI, approximately 14 to 115; p = 0.012), respectively, greater for the
SFC group than that for the placebo group. The differences in response to treatment
were significant (all p < 0.0001) in former or current smokers but not in never-smokers
(p > 0.05). The mean improvement in the total SGRQ score for the SFC group was 5.74
(p < 0.01) greater than that for the placebo group. SFC significantly reduced the
frequency of nighttime awakenings and the use of relief bronchodilator. The adjusted
ratio of exacerbations of COPD for the SFC group relative to the placebo group was
0.61 (95% CI, approximately 0.45 to 0.84; p < 0.01). There were no significant differences
between the SFC and placebo groups in safety measures.
SFC therapy achieved sustained improvement in lung function, quality of life, and
control of symptoms, and was well tolerated in Chinese patients. Greater improvements
in lung function were found only for COPD patients with a history of smoking.
http://ctr.gsk.co.uk/Summary/fluticasone_salmeterol/studylist.asp Identifier: No.
SCO100540.