Table 1.
Study demographics
| |
|
Placebo |
AZD9164 |
Total |
||
|---|---|---|---|---|---|---|
| GMAD, healthy subjects | n = 9 | 400 μg n = 6 | 1000 μg n = 6 | 2800 μg n = 6 | n = 27 | |
| Age (yrs) |
Mean |
26 |
21 |
23 |
22 |
23 |
| SD |
6 |
1 |
3 |
2 |
4 |
|
|
aBMI (kg/m2) |
Mean |
23.1 |
23.4 |
21.7 |
21.6 |
22.5 |
| SD |
1.7 |
1.8 |
2.2 |
1.1 |
1.8 |
|
|
aWeight (kg) |
Mean |
73.8 |
80.3 |
70.7 |
70.0 |
73.7 |
| |
SD |
6.8 |
8.1 |
7.4 |
4.7 |
7.6 |
|
JMAD, healthy subjects |
|
n = 6 |
400 μg n = 6 |
1000 μg n = 6 |
– |
n = 18 |
| Age (years) |
Mean |
Mean 29.8 |
29.0 |
27.5 |
– |
28.8 |
| SD |
4.9 |
4.0 |
3.4 |
– |
4.0 |
|
|
aBMI (kg/m2) |
Mean |
21.0 |
20.7 |
20.6 |
– |
20.8 |
| |
SD |
1.2 |
2.3 |
1.4 |
– |
1.6 |
|
aWeight (kg) |
Mean |
61.3 |
63.6 |
61.4 |
– |
62.1 |
| |
SD |
4.3 |
7.7 |
5.5 |
– |
5.8 |
|
GMAD, COPD patients |
|
n = 1 |
– |
1000 μg n = 3 |
– |
n = 4 |
| Age (yrs) |
Mean |
71 |
– |
64 |
– |
66 |
| |
SD |
NC |
– |
7 |
– |
6 |
|
aBMI (kg/m2) |
Mean |
23.0 |
– |
27.8 |
|
26.6 |
| |
SD |
NC |
– |
4.0 |
|
4.0 |
|
aWeight (kg) |
Mean |
77.1 |
– |
73.9 |
– |
74.7 |
| |
SD |
NC |
– |
8.1 |
– |
6.8 |
|
bFEV1 (L) |
Mean |
1.62 |
– |
1.48 |
– |
1.52 |
| |
SD |
NC |
– |
0.53 |
– |
0.43 |
|
bFEV1 (% predicted) |
Mean |
48.80 |
– |
64.63 |
– |
60.67 |
| |
SD |
NC |
– |
17.82 |
– |
16.57 |
|
bFEV1/FVC (%) |
Mean |
31.95 |
– |
49.45 |
– |
45.08 |
| |
SD |
NC |
– |
5.66 |
– |
9.90 |
| Smoking history (%) |
Current |
1 (100) |
– |
2 (67) |
|
3 (75) |
| |
Former |
0 (0) |
|
1 (33) |
|
1 (25) |
| Years since diagnosis |
Mean |
5 |
|
10 |
|
9 |
| SD | NC | 9 | 8 | |||
aAt enrolment.
bFEV1 and FVC measurements were made after inhalation of Atrovent® (post-bronchodilator).
BMI Body mass index, NC Not calculable.