Appendix 2: Active-Control Trials (continued) Decramer 2014 Inclusions 1:1:1:1 randomization Values for UMEC/CI 62.5/25; Study 2 same as in Donohue UMEC/VI 125/25; TIO; UMEC 125 R, DB, DD, AC respectively UMEC/VI 62.5/25 (n=217) 24-weeks Exclusions UMEC/VI 125/25 (n=215) N=869 TIO 18 (n=215) Age (y): 65; 63.8; 65.2; 64.5 Asthma, α-1antitrypsin UMEC 125 (n=222) Male (%): 65; 69; 71; 67 deficiency, any clinically Current smoker (%): 42; 45; 47; 44 significant uncontrolled disease, significant ECG or ICS at stable was Smoking pack-years: 47.8±26.1; clinical lab finding, lower allowed 46.9±24.9; 54±31.6; 47.6±27.6 respiratory tract infection or ICS use (%): 47; 53; 53; 56 recent COPD exacerbation Post-albuterol FEV1% pred: 47.7±13.6; 47.1±12.9; 47.4±13.1; 46.2±13 Post-albuterol FEV1 (L): 1.32±0.49; 1.31±0.42; 1.33±0.43; 1.29±0.47 % Reversibility to albuterol: 14.9±15; 15.8±15.2; 15.5±15.6; 16.1±15.3 COPD exacerbation in previous ≥1 year NOT requiring hosp (%): 28; 35; 31; 29 *Significant versus TIO COPD exacerbation in previous ≥1 versus UMEC ⱡSignificant year requiring hosp (%): 4; 7; 7; 6 ¶All active treatments had significant improvement vs. baseline; there was no significant difference between active treatments
Appendix 2: Active-Control Trials (continued) Decramer 2014 Study 2 R, DB, DD, AC 24-weeks N=869 Inclusions same as in Donohue Exclusions Asthma, α-1antitrypsin deficiency, any clinically significant uncontrolled disease, significant ECG or clinical lab finding, lower respiratory tract infection or recent COPD exacerbation 1:1:1:1 randomization UMEC/VI 62.5/25 (n=217) UMEC/VI 125/25 (n=215) TIO 18 (n=215) UMEC 125 (n=222) ICS at stable was allowed Values for UMEC/CI 62.5/25; UMEC/VI 125/25; TIO; UMEC 125 respectively Age (y): 65; 63.8; 65.2; 64.5 Male (%): 65; 69; 71; 67 Current smoker (%): 42; 45; 47; 44 Smoking pack-years: 47.8±26.1; 46.9±24.9; 54±31.6; 47.6±27.6 ICS use (%): 47; 53; 53; 56 Post-albuterol FEV1% pred: 47.7±13.6; 47.1±12.9; 47.4±13.1; 46.2±13 Post-albuterol FEV1 (L): 1.32±0.49; 1.31±0.42; 1.33±0.43; 1.29±0.47 % Reversibility to albuterol: 14.9±15; 15.8±15.2; 15.5±15.6; 16.1±15.3 ≥1 COPD exacerbation in previous year NOT requiring hosp (%): 28; 35; 31; 29 ≥1 COPD exacerbation in previous year requiring hosp (%): 4; 7; 7; 6 *Significant versus TIO ⱡSignificant versus UMEC ¶All active treatments had significant improvement vs. baseline; there was no significant difference between active treatments
Umeclidinium_Vilanterol_Monograph.docx