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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

Endpoint

Study 207608

Study 207609

Pooled 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

n

344

342

343

342

687

684

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

n

345

343

343

344

688

687

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

 

n

348

344

344

347

692

691

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

n

349

344

344

348

693

692

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