Table. Patient Demographics and Characteristics by Treatment Group.
| Characteristics | Aclidinium (n = 1791) | Placebo (n = 1798) |
|---|---|---|
| Age, mean (SD), y | 67.1 (8.5) | 67.2 (8.3) |
| Sex, No. (%) | ||
| Male | 1059 (59.1) | 1046 (58.2) |
| Female | 732 (40.9) | 752 (41.8) |
| Race, No. (%)a | ||
| White | 1603 (89.5) | 1650 (91.8) |
| Black or African American | 165 (9.2) | 138 (7.7) |
| Otherb | 23 (1.3) | 10 (0.6) |
| Body mass index, mean (SD)c | 29.7 (6.8) | 29.5 (6.9) |
| Obese (≥30), No. (%) | 771 (43.1) | 739 (41.1) |
| Current smoker, No. (%) | 784 (43.8) | 778 (43.3) |
| COPD assessment test score, mean (SD)d | 20.7 (7.3) | 20.7 (7.2) |
| Postbronchodilator FEV1 % predicted, mean (SD) | 47.7 (14.9) | 47.8 (15.2) |
| COPD severity, No. (%) | ||
| Moderate (FEV1 ≥50% to <80% predicted) | 796 (44.4) | 808 (44.9) |
| Severe (FEV1 ≥30% to <50% predicted) | 742 (41.4) | 714 (39.7) |
| Very severe (FEV1 <30% predicted) | 220 (12.3) | 244 (13.6) |
| COPD exacerbations in previous year, No. (%)e | 1068 (59.6) | 1088 (60.5) |
| No. of prior exacerbations, No. (%) | ||
| 0 | 723 (40.4) | 710 (39.5) |
| 1 | 786 (43.9) | 810 (45.1) |
| ≥2 | 282 (15.8) | 278 (15.5) |
| COPD exacerbation rate in previous year, mean (SD) | 0.8 (0.9) | 0.8 (1.0) |
| Prior COPD-related medication, No. (%)f | 1650 (92.1) | 1678 (93.3) |
| SABA | 1217 (68.0) | 1249 (69.5) |
| LABA + ICS (fixed combination) | 838 (46.8) | 800 (44.5) |
| LAMA | 217 (12.1) | 247 (13.7) |
| Leukotriene inhibitor | 150 (8.4) | 127 (7.1) |
| SABA + SAMA | 144 (8.0) | 135 (7.5) |
| Oxygen | 124 (6.9) | 125 (7.0) |
| SAMA | 89 (5.0) | 89 (5.0) |
| Systemic corticosteroids | 70 (3.9) | 77 (4.3) |
| ICS | 69 (3.9) | 69 (3.8) |
| LABA + LAMA + ICS (free combination) | 45 (2.5) | 64 (3.6) |
| LABA + ICS (free combination) | 36 (2.0) | 52 (2.9) |
| LAMA + ICS (free combination) | 33 (1.8) | 31 (1.7) |
| LABA + LAMA (fixed combination) | 29 (1.6) | 30 (1.7) |
| Xanthines | 29 (1.6) | 30 (1.7) |
| LABA + LAMA (free combination) | 24 (1.3) | 14 (0.8) |
| LABA | 19 (1.1) | 26 (1.5) |
| Oral PDE4 inhibitor | 19 (1.1) | 24 (1.3) |
| Vaccines | 5 (0.3) | 10 (0.6) |
| Cromones | 1 (0.1) | 1 (0.1) |
| LABA + ICS fixed and LABA + LAMA fixed, separately | 1 (0.1) | 1 (0.1) |
| Monoclonal antibody | 1 (0.1) | 0 |
Abbreviations: COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; PDE4, phosphodiesterase type 4; SABA, short-acting β2-agonist; SAMA, short-acting muscarinic antagonist.
Self-reported.
Includes Asian, Native Hawaiian or other Pacific Islander, American Indian or Alaska Native, and other races.
Calculated as weight in kilograms divided by height in meters squared.
Score range of 0 to 40 with higher scores indicating more symptoms; a score >10 indicates symptomatic COPD and >20 indicates a high disease impact.
Defined as worsening of COPD symptoms (dyspnea, cough, sputum) for ≥2 consecutive days that required treatment with antibiotics and/or systemic corticosteroids or resulted in hospitalization or led to death.
Prior treatments were not mutually exclusive. Fixed combinations were defined as >1 drug in a single device; free combinations used multiple individual devices. Data included in fixed or free combinations do not appear in monotherapy categories. For prior medications that were stopped before randomization and concomitant medications that were taken before randomization and continued beyond the first dose of treatment, see eTable 3 in Supplement 1.