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

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

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 AUC_0–4h, 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 AUC_0–4h, 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

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.

ISSN: 1471-2466