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Table 4 Patient-reported outcome endpoints at Week 12 (ITT population)

From: Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials

EndpointStudy 207608Study 207609Pooled analysis
FF/UMEC/VI
N = 363
BUD/FOR+TIO
N = 365
FF/UMEC/VI
N = 366
BUD/FOR+TIO
N = 366
FF/UMEC/VI
N = 729
BUD/FOR+TIO
N = 731
SGRQ total score
n344342343342687684
LS mean (95% CI)48.8 (47.8, 49.8)48.7 (47.7, 49.7)51.8 (50.7, 52.8)51.7 (50.7, 52.8)50.3 (49.5, 51.0)50.2 (49.5, 51.0)
LS mean (95% CI) change from baseline−1.2 (−2.2, −0.2)− 1.3 (− 2.3, −0.3)−1.5 (− 2.6, −0.4)−1.5 (− 2.6, − 0.4)−1.4 (− 2.1, − 0.6)−1.4 (− 2.1, − 0.6)
Treatment difference (95% CI)
p-value
0.1 (− 1.3, 1.5)
0.926
0.0 (− 1.5, 1.6)
0.974
0.0 (− 1.0, 1.1)
0.956
n345343343344688687
Responders, n (%)117 (34)117 (34)124 (36)119 (35)241 (35)236 (34)
Odds ratio (95% CI)
p-value
1.01 (0.74, 1.40)
0.928
1.09 (0.79, 1.50)
0.609
1.05 (0.84, 1.31)
0.671
CAT score 
n348344344347692691
LS mean (95% CI)19.8 (19.3, 20.3)20.4 (19.8, 20.9)21.1 (20.6, 21.6)21.2 (20.7, 21.7)20.4 (20.1, 20.8)20.8 (20.4, 21.1)
LS mean (95% CI) change from baseline−0.8 (−1.4, −0.3)−0.2 (−0.8, 0.3)− 0.2 (− 0.7, 0.3)−0.1 (− 0.6, 0.4)−0.5 (− 0.9, − 0.2)−0.2 (− 0.6, 0.2)
Treatment difference (95% CI)
p-value
− 0.6 (− 1.4, 0.2)
0.141
−0.1 (− 0.8, 0.6)
0.746
−0.3 (− 0.9, 0.2)
0.201
n349344344348693692
Responders, n (%)137 (39)130 (38)126 (37)126 (36)263 (38)256 (37)
Odds ratio (95% CI)
p-value
1.07 (0.78, 1.47)
0.655
1.02 (0.74, 1.40)
0.895
1.04 (0.83, 1.30)
0.732
  1. BUD budesonide; CAT COPD Assessment Test; CI confidence interval; FF fluticasone furoate; FOR formoterol; ITT intent-to-treat; LS least squares; SGRQ St George’s Respiratory Questionnaire; TIO tiotropium; UMEC umeclidinium; VI vilanterol