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Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.
COPD 2016; 13(1):1-10COPD

Abstract

Combinations of drugs with distinct and complementary mechanisms of action may offer improved efficacy in the treatment of chronic obstructive pulmonary disease (COPD). In two 12-week, double-blind, parallel-group studies, patients with COPD were randomized 1:1:1 to once-daily umeclidinium (UMEC; 62.5 μg and 125 μg) or placebo (PBO), added to twice-daily fluticasone propionate/salmeterol (FP/SAL; 250/50 μg). In both studies, the primary efficacy measure was trough forced expiratory volume in 1 second (FEV1) at Day 85. Secondary endpoints were weighted-mean (WM) FEV1 over 0-6 hours post-dose (Day 84) and rescue albuterol use. Health-related quality of life outcomes (St. George's Respiratory Questionnaire [SGRQ] and COPD assessment test [CAT]) were also examined. Safety was assessed throughout. Both UMEC+FP/SAL doses provided statistically significant improvements in trough FEV1 (Day 85: 0.127-0.148 L) versus PBO+FP/SAL. Similarly, both UMEC+FP/SAL doses provided statistically-significant improvements in 0-6 hours post-dose WM FEV1 versus PBO+FP/SAL (Day 84: 0.144-0.165 L). Rescue use over Weeks 1-12 decreased with UMEC+FP/SAL in both studies versus PBO+FP/SAL (Study 1, 0.3 puffs/day [both doses]; Study 2, 0.5 puffs/day [UMEC 125+FP/SAL]). Decreases from baseline in CAT score were generally larger for both doses of UMEC+FP/SAL versus PBO+FP/SAL (except for Day 84 Study 2). In Study 1, no differences in SGRQ score were observed between UMEC+FP/SAL and PBO+FP/SAL; however, in Study 2, statistically significant improvements were observed with UMEC 62.5+FP/SAL (Day 28) and UMEC 125+FP/SAL (Days 28 and 84) versus PBO+FP/SAL. The incidence of on-treatment adverse events across all treatment groups was 37-41% in Study 1 and 36-38% in Study 2. Overall, these data indicate that the combination of UMEC+FP/SAL can provide additional benefits over FP/SAL alone in patients with COPD.

Authors+Show Affiliations

a Midwest Chest Consultants, PC, St. Charles , Missouri , USA.b Clinical Research Institute of Southern Oregon , Medford , Oregon , USA.c GSK, Respiratory and Immuno-Inflammation, Research Triangle Park , North Carolina , USA.d GSK, Respiratory Medicines Development Centre, Stockley Park , Uxbridge , United Kingdom.c GSK, Respiratory and Immuno-Inflammation, Research Triangle Park , North Carolina , USA.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26451734

Citation

Siler, Thomas M., et al. "Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients With COPD: Results of Two Randomized, Double-Blind Studies." COPD, vol. 13, no. 1, 2016, pp. 1-10.
Siler TM, Kerwin E, Singletary K, et al. Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies. COPD. 2016;13(1):1-10.
Siler, T. M., Kerwin, E., Singletary, K., Brooks, J., & Church, A. (2016). Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies. COPD, 13(1), pp. 1-10. doi:10.3109/15412555.2015.1034256.
Siler TM, et al. Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients With COPD: Results of Two Randomized, Double-Blind Studies. COPD. 2016;13(1):1-10. PubMed PMID: 26451734.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies. AU - Siler,Thomas M, AU - Kerwin,Edward, AU - Singletary,Karen, AU - Brooks,Jean, AU - Church,Alison, Y1 - 2015/10/09/ PY - 2015/10/10/entrez PY - 2015/10/10/pubmed PY - 2016/10/19/medline KW - bronchodilation KW - inhaled corticosteroid KW - long-acting beta agonist KW - long-acting muscarinic antagonist SP - 1 EP - 10 JF - COPD JO - COPD VL - 13 IS - 1 N2 - Combinations of drugs with distinct and complementary mechanisms of action may offer improved efficacy in the treatment of chronic obstructive pulmonary disease (COPD). In two 12-week, double-blind, parallel-group studies, patients with COPD were randomized 1:1:1 to once-daily umeclidinium (UMEC; 62.5 μg and 125 μg) or placebo (PBO), added to twice-daily fluticasone propionate/salmeterol (FP/SAL; 250/50 μg). In both studies, the primary efficacy measure was trough forced expiratory volume in 1 second (FEV1) at Day 85. Secondary endpoints were weighted-mean (WM) FEV1 over 0-6 hours post-dose (Day 84) and rescue albuterol use. Health-related quality of life outcomes (St. George's Respiratory Questionnaire [SGRQ] and COPD assessment test [CAT]) were also examined. Safety was assessed throughout. Both UMEC+FP/SAL doses provided statistically significant improvements in trough FEV1 (Day 85: 0.127-0.148 L) versus PBO+FP/SAL. Similarly, both UMEC+FP/SAL doses provided statistically-significant improvements in 0-6 hours post-dose WM FEV1 versus PBO+FP/SAL (Day 84: 0.144-0.165 L). Rescue use over Weeks 1-12 decreased with UMEC+FP/SAL in both studies versus PBO+FP/SAL (Study 1, 0.3 puffs/day [both doses]; Study 2, 0.5 puffs/day [UMEC 125+FP/SAL]). Decreases from baseline in CAT score were generally larger for both doses of UMEC+FP/SAL versus PBO+FP/SAL (except for Day 84 Study 2). In Study 1, no differences in SGRQ score were observed between UMEC+FP/SAL and PBO+FP/SAL; however, in Study 2, statistically significant improvements were observed with UMEC 62.5+FP/SAL (Day 28) and UMEC 125+FP/SAL (Days 28 and 84) versus PBO+FP/SAL. The incidence of on-treatment adverse events across all treatment groups was 37-41% in Study 1 and 36-38% in Study 2. Overall, these data indicate that the combination of UMEC+FP/SAL can provide additional benefits over FP/SAL alone in patients with COPD. SN - 1541-2563 UR - https://www.unboundmedicine.com/medline/citation/26451734/Efficacy_and_Safety_of_Umeclidinium_Added_to_Fluticasone_Propionate/Salmeterol_in_Patients_with_COPD:_Results_of_Two_Randomized_Double_Blind_Studies_ L2 - http://www.tandfonline.com/doi/full/10.3109/15412555.2015.1034256 DB - PRIME DP - Unbound Medicine ER -