Table 1.
Patient Demographics And Characteristics (China ITT Population)
| Parameter | GFF MDI 18/9.6 µg n=146 | GP MDI 18 µg n=122 | FF MDI 9.6 µg n=135 | Placebo MDI n=63 |
|---|---|---|---|---|
| Mean age, years (SD) | 64.1 (6.4) | 63.5 (8.0) | 63.0 (7.6) | 63.5 (6.2) |
| Male, n (%) | 140 (95.9) | 116 (95.1) | 130 (96.3) | 60 (95.2) |
| Race, n (%) | ||||
| Asian | 146 (100) | 122 (100) | 135 (100) | 63 (100) |
| Mean BMI, kg/m2 (SD) | 22.9 (3.3) | 23.3 (3.3) | 22.8 (3.3) | 23.2 (3.4) |
| Smoking status, n (%) | ||||
| Current | 50 (34.2) | 42 (34.4) | 43 (31.9) | 20 (31.7) |
| Former | 96 (65.8) | 80 (65.6) | 92 (68.1) | 43 (68.3) |
| Mean number of pack-years smokeda (SD) | 37.0 (23.8) | 34.7 (21.0) | 39.7 (22.6) | 34.9 (19.8) |
| COPD severityb, n (%) | ||||
| Mildc | 3 (2.1) | 7 (5.7) | 3 (2.2) | 4 (6.3) |
| Moderate | 78 (53.4) | 66 (54.1) | 72 (53.3) | 29 (46.0) |
| Severe | 59 (40.4) | 45 (36.9) | 56 (41.5) | 29 (46.0) |
| Very severe | 6 (4.1) | 4 (3.3) | 4 (3.0) | 1 (1.6) |
| Mean COPD duration, years (SD) | n=141 | n=122 | n=132 | n=62 |
| 4.2 (5.5) | 3.7 (5.0) | 3.5 (4.2) | 4.3 (5.5) | |
| Mean post-bronchodilator FEV1, % predicted (SD) | 53.33 (14.76) | 54.45 (14.81) | 53.55 (14.01) | 53.62 (15.84) |
| Reversibility to salbutamol | ||||
| Reversibled, n (%) | 76 (52.1) | 60 (49.2) | 63 (46.7) | 32 (50.8) |
| Mean reversibility post-bronchodilator, % (SD) | 20.9 (16.1) | 20.4 (14.7) | 19.8 (13.9) | 20.6 (15.3) |
| Prior use of ICSe, n (%) | 49 (33.6) | 39 (32.0) | 56 (41.5) | 27 (42.9) |
| Mean BDI score (SD) | n=142 | n=119 | n=129 | n=59 |
| 7.0 (2.1) | 7.1 (2.0) | 7.3 (2.1) | 6.4 (2.3) | |
| Mean baseline SGRQ total score (SD) | n=129 | n=110 | n=116 | n=53 |
| 36.0 (15.5) | 33.2 (15.3) | 32.6 (14.0) | 34.9 (12.0) | |
| Mean CAT total scoref (SD) | n=145 | n=121 | n=135 | n=63 |
| 12.0 (6.0) | 12.3 (6.8) | 11.7 (6.0) | 11.0 (5.9) | |
| Mean rescue medication useg at baseline, puffs/day (SD) | n=45 | n=39 | n=44 | n=16 |
| 3.6 (3.1) | 3.5 (2.4) | 3.2 (2.3) | 4.4 (4.4) |
Notes: aNumber of pack-years smoked = (number of cigarettes each day/20) × number of years smoked. bSeverity of COPD was based on the non-missing post-salbutamol assessment at screening. cThese patients were characterized as having mild COPD due to the application of an Asian correction factor to baseline lung function assessments at the time of analysis. dReversible is defined as improvement in FEV1 post-salbutamol administration compared to pre-salbutamol of ≥12% and ≥200 mL. eDefined as using ICS on the day of the first dose of study medication. fCAT total score is the sum of eight CAT item scores (range: 0–40). gRescue medication use was analyzed in the China rescue medication user population, defined as all patients in the China ITT population with mean baseline rescue salbutamol use of ≥1 puff/day.
Abbreviations: BDI, Baseline Dyspnea Index; BMI, body mass index; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; FF, formoterol fumarate; GFF, glycopyrrolate/formoterol fumarate; GP, glycopyrrolate; ICS, inhaled corticosteroid; ITT, intent-to-treat; MDI, metered dose inhaler; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire.