Table 2.
Patient demographics at baseline and characteristics during the study run-in period by poly-C repeat genotypes
| Poly-C genotype | 10a/11a | 10a/12a | 11a/11a | 10a/13b | 11a/12a | 11a/13b | 12a/12a | 11a/14b | 12a/13b | 12a/14b | 13b/13b | 13b/14b | Genotypes <1% | Undetermined |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients, n (%) |
44 (2) |
57 (3) |
225 (10) |
62 (3) |
314 (14) |
418 (19) |
136 (6) |
74 (3) |
357 (16) |
77 (3) |
211 (9) |
119 (5) |
98 (4) |
58 (3) |
| Ethnic origin, n (%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Whitea |
39 (2) |
33 (2) |
204 (12) |
32 (2) |
277 (17) |
349 (21) |
86 (5) |
59 (4) |
212 (13) |
53 (3) |
141 (9) |
72 (4) |
51 (3) |
26 (2) |
| Black |
2 (10) |
0 |
1 (5) |
4 (19) |
0 |
1 (5) |
0 |
0 |
2 (10) |
0 |
2 (10) |
2 (10) |
5 (24) |
2 (10) |
| Asian |
0 |
12 (8) |
0 |
15 (10) |
4 (3) |
3 (2) |
11 (7) |
0 |
48 (31) |
8 (5) |
21 (13) |
15 (10) |
18 (12) |
1 (1) |
| Other |
3 (1) |
12 (3) |
20 (5) |
11 (3) |
33 (8) |
65 (15) |
39 (9) |
15 (3) |
95 (22) |
16 (4) |
47 (11) |
30 (7) |
24 (5) |
29 (7) |
| Men, n (%) |
17 (1) |
25 (1) |
98 (4) |
28 (1) |
134 (6) |
183 (8) |
52 (2) |
37 (2) |
132 (6) |
29 (1) |
78 (3) |
45 (2) |
53 (2) |
20 (1) |
| Age, mean (SD), years |
39.9 (15.4) |
36.1 (15.8) |
39.9 (15.9) |
34.8 (16.5) |
39.5 (16.7) |
39.1 (17.4) |
36.5 (16.7) |
38.6 (17.0) |
37.3 (17.1) |
35.2 (16.8) |
35.9 (15.8) |
39.0 (16.8) |
34.5 (16.3) |
35.6 (17.1) |
| FEV1, mean (SD), L |
2.2 (0.6) |
2.2 (0.6) |
2.3 (0.6) |
2.2 (0.7) |
2.3 (0.7) |
2.3 (0.7) |
2.2 (0.6) |
2.3 (0.7) |
2.2 (0.7) |
2.3 (0.6) |
2.2 (0.7) |
2.1 (0.8) |
2.2 (0.7) |
2.1 (0.6) |
| FEV1, mean (SD), % predicted |
73.6 (14.3) |
72.3 (12.3) |
73.4 (13.4) |
70.9 (13.4) |
73.7 (14.1) |
73.1 (12.9) |
72.7 (12.6) |
73.5 (11.5) |
72.5 (13.5) |
74.2 (13.1) |
72.3 (13.9) |
73.1 (16.0) |
69.5 (12.8) |
70.7 (13.5) |
| FEV1 reversibility, mean (SD), % |
25.6 (16.4) |
24.2 (11.6) |
23.6 (12.9) |
22.2 (11.0) |
24.4 (12.3) |
24.0 (12.2) |
25.4 (12.6) |
24.5 (12.9) |
25.6 (14.3) |
26.4 (16.6) |
24.7 (11.7) |
22.9 (10.8) |
24.1 (13.9) |
26.5 (12.8) |
| FVC, mean (SD), L |
2.9 (0.7) |
3.0 (0.8) |
3.2 (1.0) |
2.9 (0.9) |
3.2 (1.0) |
3.1 (0.9) |
3.0 (0.9) |
3.1 (0.9) |
2.9 (1.0) |
3.0 (0.9) |
3.0 (1.0) |
2.9 (0.9) |
3.0 (1.0) |
2.8 (0.7) |
| ICS dose at study entry, mean (SD), μg per day |
747.7 (261.9) |
750.0 (195.5) |
766.0 (249.6) |
796.0 (232.6) |
734.1 (216.4) |
749.0 (243.6) |
701.8 (207.0) |
776.4 (239.0) |
708.0 (221.5) |
734.4 (254.7) |
745.3 (250.5) |
694.5 (189.3) |
713.8 (191.9) |
736.2 (236.0) |
| Morning PEF during run-in, mean (SD), L/min |
322.1 (88.7) |
331.4 (103.5) |
341.6 (98.1) |
338.4 (99.6) |
340.7 (92.7) |
334.9 (99.0) |
337.8 (82.3) |
350.5 (95.1) |
321.6 (92.0) |
342.2 (90.6) |
333.1 (85.6) |
320.3 (98.3) |
358.7 (106.8) |
316.5 (76.7) |
| Total rescue medication use during run-in, mean (SD), inhalations/day |
2.2 (1.1) |
2.5 (1.6) |
2.5 (1.6) |
2.5 (1.4) |
2.3 (1.4) |
2.4 (1.5) |
2.2 (1.5) |
2.4 (1.4) |
2.2 (1.2) |
2.1 (1.1) |
2.3 (1.2) |
2.4 (1.3) |
2.2 (1.3) |
3.1 (2.2) |
| Nights with awakenings during run-in, mean (SD), % |
32.6 (35.9) |
33.8 (33.8) |
31.8 (34.6) |
33.5 (33.7) |
35.7 (35.0) |
32.2 (34.0) |
33.5 (35.5) |
34.5 (37.0) |
33.4 (35.1) |
35.7 (36.9) |
33.7 (35.8) |
29.8 (35.1) |
32.9 (36.7) |
47.1 (35.6) |
| Total symptom score, mean (SD) | 1.9 (0.7) |
2.0 (0.9) |
1.9 (0.9) |
1.9 (0.9) |
2.0 (0.9) |
2.0 (0.9) |
1.9 (1.0) |
2.0 (0.9) |
1.9 (0.9) |
1.8 (0.7) |
2.0 (0.9) |
2.1 (1.0) |
1.9 (1.0) |
2.2 (1.1) |
aWhites of European descent.
Baseline and run-in characteristics for patients of all races. Genotypes present at a frequency of <1% are grouped together, and patients whose poly-C genotype was undetermined are grouped together. FEV1 = forced expiratory volume in one second; FVC = forced vital capacity; ICS = inhaled corticosteroid; PEF = peak expiratory flow; SD = standard deviation.