Table 1.
Summary of patient population (mITT population), (a) demographic characteristics (b) screening parameters
|
a. | ||
|---|---|---|
| Characteristic |
Total |
|
| N = 163 | ||
| Age (yr) |
|
|
| Mean (SD) |
59.5 (9.21) |
|
| Sex, n (%) |
|
|
| Male |
78 (48) |
|
| Ethnicity, n (%) |
|
|
| Hispanic/Latino |
1 (<1) |
|
| Non-Hispanic/Latino |
162 (>99) |
|
| Race, n (%) |
|
|
| White |
145 (89) |
|
| African American/African heritage |
16 (10) |
|
| African American/African heritage and White |
1 (<1) |
|
| American Indian or Alaskan native |
1 (<1) |
|
| Height (cm) |
||
| Mean (SD) |
170.2 (9.20) |
|
| Weight (kg) |
||
| Mean (SD) |
79.55 (17.539) |
|
| Body mass index (kg/m2) |
||
| Mean (SD) |
27.36 (5.115) |
|
|
b. | ||
|
Parameter |
Total N = 163 |
|
|
Pre-salbutamol |
Post-salbutamol |
|
| % predicted FEV1 (%) |
|
|
| n |
162 |
163 |
| Mean (SD) |
47.0 (12.84) |
51.1 (10.16) |
| FEV1/FVC (%) |
|
|
| n |
162 |
163 |
| Mean (SD) |
51.1 (11.65) |
52.3 (10.62) |
| FEV1 (L) |
|
|
| n |
162 |
163 |
| Mean (SD) |
1.429 (0.5179) |
1.554 (0.4727) |
| FVC (L) |
|
|
| n |
162 |
163 |
| Mean (SD) |
2.803 (0.7948) |
3.001 (0.8073) |
| Reversibility to salbutamol (%) |
|
|
| n |
162 |
|
| Mean (SD) |
11.8 (15.31) |
|
| Reversibility to salbutamol (mL) |
|
|
| n |
162 |
|
| Mean (SD) |
124.2 (212.56) |
|
| Mean baseline FEV1 (L) |
|
|
| n |
163 |
|
| Mean (SD) |
1.408 (0.5282) |
|
| Mean baseline FVC (L) |
|
|
| n |
163 |
|
| Mean (SD) | 2.763 (0.7920) | |
Note: mean baseline was defined as the mean of the baseline values from each treatment period. If one or more values were missing, the mean baseline was the mean of the non-missing values.
FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; mITT, modified intent-to-treat; SD, standard deviation; UMEC, umeclidinium bromide.