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

From: Glycopyrrolate/formoterol fumarate metered dose inhaler for maintenance-naïve patients with chronic obstructive pulmonary disease: a post-hoc analysis of the randomized PINNACLE trials

 NMTMT
TreatmentGFFFFGPPlaceboGFFFFGPPlacebo
Time to first CID
 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, weeks20.116.116.012.116.313.314.99.1
 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-value0.01570.0018< 0.00010.0012< 0.0001< 0.0001
SGRQ total score at Week 24
 n528465436200814668681319
 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-value0.29030.61790.08100.17350.0003< 0.0001
Rescue salbutamol use over 24 weeks (rescue medication user analysis set)
 n347312299138565492519276
 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-value0.38450.2740< 0.00010.0046< 0.0001< 0.0001
  1. All P-values < 0.05 should only be interpreted in terms of nominal significance as the analyses in these subgroups were exploratory and post-hoc. Numbers rounded to 2 decimal places. CI Confidence interval, FF Formoterol fumarate, GFF Glycopyrrolate/formoterol fumarate, GP Glycopyrrolate, LSM Least squares mean, MDI Metered dose inhaler, MT Maintenance-treated at screening, NMT Not maintenance-treated at screening, SD Standard deviation, SE Standard error, SGRQ St George’s Respiratory Questionnaire