PURPOSE: To establish the efficacy and tolerability of fluticasone propionate 500mcg/salmeterol 50ug (FSC 500/50) bid added to usual COPD therapy in Chinese patients.
METHODS: This was a multicentre, randomised, double-blind, placebo-controlled parallel group study. 445 patients with COPD having post-bronchodilator forced expiratory volume in 1 second (FEV1) of 25-70% of predicted at baseline were randomized to receive either inhaled FSC (n=297), or placebo (n=148) twice daily for 24 weeks. The primary endpoint was the change from baseline in pre-bronchodilator FEV1. Secondary endpoints were the change in quality of life determined by the St. Georges Respiratory Questionnaire (SGRQ) score, relief bronchodilator use, night-time awakenings, post-bronchodilator FEV1, frequency of exacerbations. Safety assessment included adverse events, electrocardiograms, vital signs, lab tests and oropharyngeal examination.
RESULTS: FSC 500/50 provided significant and sustained improvement of pre- and post-bronchodilator FEV1. After 24 weeks treatment, the mean change of pre- and post-bronchodilator FEV1 in the FSC 500/50 group were 0.180L higher (95% CI 0.091∼0.268, p<0.0001) and 0.065L higher than that of the placebo group (95%CI 0.014∼0.115, p=0.012) respectively. The mean improvement in the SGRQ total score, symptom score, activity score and impact score in the FSC group was 5.740, 9.669, 4.825 and 5.225 greater than the placebo group, respectively (all p<0.01). FSC also reduced the frequency of night-time awakening (p<0.05) and the usage of relief bronchodilators (p<0.05). The adjusted exacerbation ratio of FSC group to placebo group was 0.61 (95% CI 0.45•0.84, p<0.01). FSC 500/50 was well tolerated. No differences were found between FSC and placebo groups in frequency and nature of adverse events, as well as other safety profiles.
CONCLUSION: FSC added to usual COPD therapy achieved sustained improvement of lung function, quality of life and control of symptoms and was well tolerated without increased safety concern in Chinese patients.
CLINICAL IMPLICATIONS: FSC 500/50 can provide a valuable treatment option for Chinese patients with COPD.
DISCLOSURE: Jingping Zheng, None.