Decramer 2014 1:1:1:1 randomization Values for UMEC/CI 62.5/25; Inclusions 1 same as in Donohue UMEC/VI 125/25; TIO; VI R, DB, DD, AC respectively UMEC/VI 62.5/25 (n=207) 24-weeks UMEC/VI 125/25 (n=204) Exclusions N=843 TIO 18 (n=203) 63; 62.9; 62.6; 63.2 Asthma, Age (y): α-1antitrypsin VI 25 (n=205) 69.8; 70.6; 67.3; 68.4 deficiency, any clinically Male (%): significant uncontrolled disease, significant ECG or ICS at stable doses was 46; 58; 48; 51 Current smoker (%): clinical lab finding, lower allowed Smoking 44.8±27.7; respiratory tract infection or 43.5±25; 41.9±24.4; 41.6±25.4 recent COPD exacerbation 44; 48; 43; 40 ICS use (%): Post-albuterol FEV1% pred: 48±12.9; 47.2±12.8; 47.8±13.4; 47.7.2±12.7 % Reversibility to albuterol: *Significant vs. TIO and VI 12.4±15; 12.2±14.2; 10.8±13.6; active treatments had significant improvement vs. baseline; there was no significant ‡All difference between active treatments 11.3±13.7 §Significant vs. TIO COPD exacerbation in previous ≥1 year NOT requiring hosp (%): 30; 28; 34; 31 COPD exacerbation in previous ≥1 15; 11; 19; year requiring hosp (%): 16
Decramer 2014 1 R, DB, DD, AC 24-weeks N=843 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=207) UMEC/VI 125/25 (n=204) TIO 18 (n=203) VI 25 (n=205) ICS at stable doses was allowed Values for UMEC/CI 62.5/25; UMEC/VI 125/25; TIO; VI respectively Age (y): 63; 62.9; 62.6; 63.2 Male (%): 69.8; 70.6; 67.3; 68.4 Current smoker (%): 46; 58; 48; 51 Smoking 44.8±27.7; 43.5±25; 41.9±24.4; 41.6±25.4 ICS use (%): 44; 48; 43; 40 Post-albuterol FEV1% pred: 48±12.9; 47.2±12.8; 47.8±13.4; 47.7.2±12.7 % Reversibility to albuterol: 12.4±15; 12.2±14.2; 10.8±13.6; 11.3±13.7 ≥1 COPD exacerbation in previous year NOT requiring hosp (%): 30; 28; 34; 31 ≥1 COPD exacerbation in previous year requiring hosp (%): 15; 11; 19; 16 *Significant vs. TIO and VI ‡All active treatments had significant improvement vs. baseline; there was no significant difference between active treatments §Significant vs. TIO
Umeclidinium_Vilanterol_Monograph.docx