Table 2 Clinically important deterioration (CID) and patient-reported outcomes

 Patients with CID, n/N (%)

349/638 (54.7)

331/548 (60.4)

323/516 (62.6)

169/241 (70.1)

576/947 (60.8)

514/812 (63.3)

576/846 (68.1)

334/435 (76.8)

 Median time to CID, weeks

20.1

16.1

16.0

12.1

16.3

13.3

14.9

9.1

 Hazards ratio vs GFF MDI (95% CI)

–

0.83 (0.71, 0.97)

0.79 (0.67, 0.91)

0.57 (0.48, 0.69)

–

0.82 (0.73, 0.92)

0.77 (0.68, 0.86)

0.48 (0.42, 0.55)

P-value

–

0.0157

0.0018

< 0.0001

–

0.0012

< 0.0001

< 0.0001

 n

528

465

436

200

814

668

681

319

 Baseline score, mean (SD)

45.00 (17.52)

45.63 (18.30)

44.29 (18.65)

45.34 (17.83)

45.25 (17.54)

43.24 (17.52)

44.51 (17.95)

44.79 (17.94)

 Change from baseline, LSM (SE)

−4.40 (0.52)

−5.21 (0.56)

−4.01 (0.58)

−2.65 (0.86)

−4.13 (0.41)

−3.29 (0.46)

−1.954 (0.45)

−0.86 (0.66)

 Treatment difference vs GFF MDI (95% CI)

–

0.81 (− 0.69, 2.31)

− 0.39 (− 1.92, 1.14)

−1.75 (− 3.71, 0.22)

–

− 0.83 (− 2.04, 0.37)

−2.17 (− 3.36, − 0.99)

−3.26 (− 4.78, − 1.75)

P-value

–

0.2903

0.6179

0.0810

–

0.1735

0.0003

< 0.0001

 n

347

312

299

138

565

492

519

276

 Change from baseline in rescue salbutamol use (SE), puffs/day

−1.5 (0.13)

−1.4 (0.14)

− 1.3 (0.14)

−0.6 (0.21)

−1.5 (0.10)

− 1.1 (0.11)

− 0.6 (0.11)

0.01 (0.15)

 Treatment difference vs GFF MDI (95% CI), puffs/day

–

−0.2 (− 0.5, 0.2)

−0.2 (− 0.6, 0.2)

−0.9 (− 1.4, − 0.5)

–

−0.4 (− 0.7, − 0.1)

−0.8 (− 1.1, − 0.6)

− 1.5 (− 1.9, − 1.2)

P-value

–

0.3845

0.2740

< 0.0001

–

0.0046

< 0.0001

< 0.0001