Table 3

Change in efficacy measures

Efficacy measureFemale*Male*
Placebo
(N=21)
GSK2881078
(N=21)
Treatment difference (N=21) at
day 90
(90% CI)
Placebo
(N=23)
GSK2881078
Baseline
(N=23)
Treatment difference (N=21) at
day 90
(90% CI)
Baseline mean (SD)†Change at
day 90 adjusted mean (90% CI)†
Baseline mean (SD)†Change at
day 90 adjusted mean (90% CI)†
Baseline mean (SD)†Change at
day 90 adjusted mean (90% CI)†
Baseline mean (SD)†Change at
day 90 adjusted mean (90% CI)†
1-RM (kg)109.2
(40.12)
12.3
(5.1 to 19.6)
120.0
(45.81)
20.3
(12.8 to 27.8)
8.0
(−2.5 to 18.4)
168.8
(55.11)
14.2
(5.5 to 22.9)
202.3
(59.79)
26.0
(17.7 to 34.3)
11.8
(−0.5, 24.0)
1-RM (% change from baseline)12.8
(5.9 to 19.6)
17.9
(10.9 to 25.0)
5.2
(−4.7, 15.0)
7.2
(2.5 to 11.8)
14.2
(9.7 to 18.6)
7.0
(0.5 to 13.6)
tLBM (kg)36.6
(5.04)
−0.5
(−1.1 to 0.0)
36.9
(4.99)
1.6
(1.0 to 2.2)
2.1
(1.3 to 3.0)
51.4
(8.41)
−0.4
(−1.3 to 0.4)
52.4
(7.09)
1.7
(0.9 to 2.5)
2.1
(1.0 to 3.3)
SPPB score9.5
(1.47)
0.3
(−0.2, 0.7)
9.6
(1.56)
0.5
(0.0, 1.0)
0.2
(−0.4, 0.9)
10.1
(1.20)
0.4
(0.0, 0.8)
9.9
(1.29)
0.5
(−0.5 to 0.8)
0.1
(−0.5 to 0.6)
5STS (s)16.2
(6.51)
−1.1
(−2.2 to 0.1)
15.6
(5.14)
−2.3
(−3.3 to –0.8)
−1.0
(−2.7 to 0.8)
13.7
(2.24)
1.1
(−1.2 to 3.5)
13.9
(2.34)
−0.8
(−3.1 to 1.5)
−1.9
(−5.2 to 1.3)
4mGS (s)4.60
(1.08)
−0.0
(−0.4 to 0.3)
4.5
(1.19)
−0.1
(−0.5 to 0.3)
−0.0
(−0.6, 0.5)
4.5
(1.06)
−0.1
(0.4, 0.1)
4.6
(1.11)
−0.4
(−0.6 to –0.2)
−0.2
(−0.5, 0.1)
ESWT (s)224.6
(78.93)
−6.5
(−51.9 to 38.8)
316.1
(251.91)
4.6
(−45.0 to 54.1)
11.1
(−57.1 to 79.2)
253.4
(121.42)
105.1
(12.3 to 197.9)
297.0
(116.39)
−44.2
(−132.1 to 43.6)
−149.3
(−280.6 to 18.1)
ISWT (m)318
(106.38)
−10.5
(−35.5 to 14.4)
363.8
(144.41)
−17.2
(−42.9 to 8.4)
−6.7
(−42.7 to 29.2)
341.3
(105.41)
−7.5
(−34.2 to 19.3)
399.1
(143.75)
−42.3
(-67.6 to –16.9)
−34.8
(−72.0 to 2.4)
CAT score20.2
(6.08)
−1.3
(−2.6 to 0.1)
18.1
(6.86)
−2.2
(−3.6 to –0.7)
−0.9
(−2.9 to 1.1)
17.6
(6.18)
−1.4
(−3.0 to 0.1)
16.7
(6.98)
0.8
(−0.7 to 2.3)
2.2
(0.0 to 4.5)
SGRQ-C score48.4
(15.88)
−3.9
(−6.8 to –1.0)
41.8
(13.69)
−0.9
(−4.1 to 2.3)
3.0
(−1.4 to 7.4)
43.5
(14.89)
−1.7
(−4.9 to 1.5)
39.5
(16.69)
0.4
(−0.2.6 to 3.4)
2.1
(−2.3 to 6.5)
  • *Results for analysis population (N=21 each for female placebo and GSK2881078 groups and N=23 each for male placebo and GSK2881078 groups; for individual analyses, n ranged from 16 to 23).

  • †Results reported as mean (SE) for baseline visits, adjusted means (90% CIs) for repeated measures mixed models for endpoints measured at more than one study time point, and as mean (90% CIs).

  • CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; ESWT, endurance shuttle walk test; ISWT, incremental shuttle walk test; 4mGS, 4 m gait speed; 1-RM, one-repetition maximum; SGRQ-C, St George’s Respiratory Questionnaire-COPD; SPPB, short physical performance battery; 5STS, five-repetition sit-to-stand; tLBM, total lean body mass.