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document
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD . BACKGROUND Combining maintenance medications with different mechanisms of action may improve outcomes in COPD . In this study we evaluated the efficacy and safety of fluticasone/salmeterol ( FSC ) ( 250/50 mcg twice daily ) when added to tiotropium ( 18 mcg once daily ) ( TIO ) in subjects with symptomatic moderate to severe COPD . METHODS This was a 24-week , randomized , double-blind , parallel group , multi-center study . Subjects 40 years or older with cigarette smoking history ≥10 pack-years and with the diagnosis of COPD and post-bronchodilator FEV ( 1 ) ≥40 to ≤ 80 % of predicted normal and FEV ( 1 ) /FVC of ≤0.70 were enrolled . Following a 4-week treatment with open-label TIO 18 mcg once daily , subjects were randomized in a double-blind fashion to either the addition of FSC 250/50 DISKUS twice daily or matching placebo . The primary efficacy endpoint was AM pre-dose FEV ( 1 ) and secondary endpoints included other measures of lung function , rescue albuterol use , health status and exacerbations . RESULTS The addition of FSC to TIO significantly improved lung function indices including AM pre-dose FEV ( 1 ) , 2 h post-dose FEV ( 1 ) , AM pre-dose FVC , 2 h post-dose FVC and AM pre-dose IC compared with TIO alone . Furthermore , this combination was superior to TIO alone in reducing rescue albuterol use . However , there were no significant differences between the treatment groups in health status or COPD exacerbations . The incidence of adverse events was similar in both groups . CONCLUSIONS The addition of FSC to subjects with COPD treated with TIO significantly improves lung function without increasing the risk of adverse events . NCT00784550 .
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Intervention_Pharmacological
fluticasone propionate/salmeterol
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Intervention_Pharmacological
tiotropium
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Intervention_Pharmacological
fluticasone/salmeterol ( FSC )
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Intervention_Pharmacological
tiotropium
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Outcome_Other
efficacy and safety
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Participant_Condition
moderate to severe COPD