Table 4

Secondary and exploratory outcomes

Efficacy measureFemale*Male*
Placebo (N=21)GSK2881078 (N=21)Placebo (N=23)GSK2881078 (N=23)
Baseline†Day 90†Baseline†Day 90†Baseline†Day 90†Baseline†Day 90†
FEV1
(% predicted)
46.4 (11.19)46.8 (11.89)48.7 (9.53)47.8 (9.87)51.9 (10.19)53.9 (10.64)47.3 (11.73)48.3 (13.13)
SnIP
(cm H2O)
66.5 (18.47)66.5 (19.76)58.1 (18.79)57.8 (19.32)78.7 (27.33)80.8 (31.99)72.2 (26.11)75.9 (30.02)
Average steps/day3097.6 (1571.42)3091.6 (1747.82)3937.1 (2790.79)4712.9 (3398.26)3361.4 (2140.77)2657.2 (1526.58)3603.5 (2138.55)4591.2 (3054.74)
D-PPAC
total score
57.7 (9.50)61.0 (11.62)60.8 (8.20)61.2 (12.25)57.6 (7.53)58.4 (7.89)60.6 (11.00)60.7 (12.40)
D-PPAC
amount average
49.4 (11.25)53.0 (12.75)49.3 (12.29)54.2 (15.04)45.6 (13.12)45.7 (10.42)52.5 (11.82)52.3 (16.51)
D-PPAC
difficulty average
66.0 (14.42)68.9 (15.05)72.3 (12.22)68.1 (16.02)69.5 (11.84)71.1 (12.63)68.7 (14.68)69.1 (16.30)
Handgrip strength (kg)‡20.9 (6.99)21.1 (5.95)21.3 (4.72)21.8 (6.08)33.4 (8.88)35.4 (8.34)34.4 (8.17)35.0 (7.85)
  • No clinically meaningful differences between GSK2881078 and placebo groups were observed for HRQoL and other patient-reported measures.

  • *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).

  • †Values reported as unadjusted mean (SD).

  • ‡Handgrip strength was measured using the right hand.

  • D-PPAC, Daily PROactive; FEV1, forced expiratory volume in 1 s; HRQoL, health-related quality of life; SnIP, sniff nasal inspiratory pressure.