| |
Mpex
|
AZ 1
|
AZ 2
|
|---|
|
(N = 235)*
|
(N = 749)†
|
(N = 597)‡
|
|---|
|
Age, mean (SD)
|
63.7 (8.95)
|
62.3 (8.25)
|
61.7 (8.27)
|
|
Gender, n (% Male)
|
113 (48.1)
|
572 (76.4)
|
443 (74.2)
|
|
Race/Ethnicity, n (%)
| | | |
|
White
|
214 (91.1)
|
536 (71.6)
|
592 (99.2)
|
|
Asian
|
2 (0.9)
|
212 (28.3)
|
0 (0.0)
|
|
Black/African American
|
18 (7.7)
|
0 (0.0)
|
0 (0.0)
|
|
Hispanic or Latino
|
6 (2.6)
|
2 (0.3)
|
2 (0.3)
|
|
FEV1, mean (SD)§
|
1.2 (0.58)
|
1.7 (0.49)
|
1.6 (0.52)
|
|
FEV1% predicted, mean (SD)
|
42.2 (18.10)
|
58.8 (12.70)
|
54.2 (15.36)
|
|
GOLD¶ stage, n (%)
| | | |
|
0
|
22 (9.4)
|
0 (0.0)
|
0 (0.0)
|
|
I
|
2 (0.9)
|
23 (3.2)
|
22 (3.8)
|
|
II
|
55 (23.4)
|
503 (69.1)
|
300 (51.9)
|
|
III
|
89 (37.9)
|
197 (27.1)
|
240 (41.5)
|
|
IV
|
66 (28.1)
|
5 (0.7)
|
16 (2.8)
|
|
SGRQ total score∥
|
57.4 (16.21)
|
52.6 (18.36)
|
54.9 (17.14)
|
|
Exercise test meters, mean (SD)
|
289 (121)**
|
392 (122)**
|
337 (185)††
|
|
RS-Total Score, mean (SD)††
|
15.7 (5.93)
|
15.9 (6.0)
|
18.2 (5.99)
|
|
RS-Breathlessness
|
8.2 (5.93)
|
7.9 (3.17)
|
8.9 (3.12)
|
|
RS-Cough and Sputum
|
4.1 (2.08)
|
4.2 (1.56)
|
4.7 (1.60)
|
|
RS-Chest Symptoms
|
3.3 (2.08)
|
3.8 (1.93)
|
4.6 (1.91)
|
- *United States.
- †Australia, Canada, Germany, Japan, Korea, Philippines, Poland, Russia, Slovakia, Taiwan, Ukraine, United States.
- ‡Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia.
- §Post-bronchodilator.
- ¶Spirometric classification GOLD 2014 [5].
- ∥Range: 0 to 100, higher scores = worse health status; SGRQ-C was used in both AZ studies.
- **6 Minute Walk Test (6MWT).
- ††Incremental Shuttle Walk Test (ISWT).
- ‡‡Baseline, mean (SD) weekly scores, Day -7 to Day 1; Ranges: RS-Total: 0 to 40; RS-Breathlessness: 0 to 17; RS-Cough and Sputum: 0 to 11; RS-Chest Symptoms: 0 to 12; higher scores = more severe symptoms.
- Abbreviations: AZ AstraZeneca, FEV
1
forced expiratory volume in 1 second, GOLD Global Initiative for Chronic Obstructive Lung Disease, SD standard deviation, SGRQ St. George's Respiratory Questionnaire, SGRQ-C St. George's Respiratory Questionnaire for COPD.
