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Table 2 Differences between treatment for primary and secondary efficacy outcomes (PPS)

From: A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study

Variable LSM (95% CI) treatment difference glycopyrronium versus tiotropium p-value
Day 1   
FEV1 5 min post-dose, L 0.051 (0.036, 0.066) <0.001
FEV1 15 min post-dose, L 0.063 (0.046, 0.079) <0.001
FVC 5 min post-dose, L 0.051 (0.013, 0.089) 0.008
FVC 15 min post-dose, L 0.050 (0.008, 0.092) 0.020
FVC 30 min post-dose, L 0.045 (0.001, 0.089) 0.046
Peak FEV1 (0–4 h), L 0.055 (0.034, 0.075) <0.001
IC 30 min post-dose, L 0.078 (0.033, 0.123) <0.001
IC 2 h post-dose, L 0.098 (0.045, 0.152) <0.001
FEV1 AUC0–4h, L 0.058 (0.040, 0.076) <0.001
Week 12   
Trough FEV1 (non inferiority; PPS; Primary objective), L 0 (−0.032, 0.031) <0.001*
Trough FEV1 (superiority; FAS), L 0.004 (−0.025, 0.034) 0.780
FEV1 AUC0–4h, L 0.023 (−0.006, 0.053) 0.120
Peak FEV1 (0–4 h), L 0.025 (−0.005, 0.055) 0.107
IC 24 h post-dose, L −0.034 (−0.101, 0.033) 0.318
TDI focal score −0.188 (−0.614, 0.237) 0.385
SGRQ total score 0.65 (−1.19, 2.50) 0.488
Over 12 weeks   
Rescue medication use   
   Change from baseline in mean daily number of puffs 0 (−0.3, 0.3) 0.852
   Percentage of days with no rescue medication use −1.5 (−6.2, 3.2) 0.528
Change from baseline in mean daily total symptom score −0.3 (−0.5, 0.0) 0.035
  1. Results of analysis in the per protocol set, unless otherwise stated; *One-sided p-value for the test of non-inferiority presented; Imputed with last observation carried forward; Scored from 0–3 for both morning and evening symptoms (0 = lowest, 3 = highest; with the possible range of 0–18 for the daily score); AUC = area under the curve; CI = confidence interval; FAS = full analysis set; FEV1 = forced expiratory volume in 1 second; FVC = forced vital capacity; IC = inspiratory capacity; LSM = least squares mean; PPS = per-protocol set; TDI = Transition Dyspnea Index; SGRQ = St George’s Respiratory Questionnaire.