A phase IIb randomized, chronic-dosing, incomplete block, cross-over study of glycopyrronium, delivered via metered dose inhaler, compared with a placebo and an active control in patients with moderate-to-severe COPD

Table 2 Secondary efficacy endpoints on Day 1 (mITT population)

	GP MDI 28.8 μg BID	GP MDI 14.4 μg BID	GP MDI 7.2 μg BID	GP MDI 3.6 μg BID	Placebo MDI BID	Ipratropium MDI 34 μg QID
Peak change from baseline in FEV₁ ^a, L
N	45	46	44	41	46	44
LSM	0.245^†	0.221^†	0.181^***	0.204^†	0.071	0.250^†
95% CI	0.195–0.295	0.172–0.270	0.130–0.232	0.153–0.255	0.021–0.120	0.198–0.301
Time to onset of action (proportion of patients achieving ≥10% improvement from baseline in FEV₁), %
N	44	45	43	40	45	44
Within 30 min	63.6	48.9	25.6	45.0	15.6	72.7
Within 2 h	70.5	73.3	62.8	67.5	33.3	84.1
Patients achieving ≥12% improvement in FEV₁, %
N	45	46	44	41	46	45
Proportion of patients	66.7^**	58.7	52.3^**	61.0^***	17.4^b	77.8
Peak change from baseline in IC^c, L
N	45	45	44	41	46	45
LSM	0.240^†	0.276^†	0.185^**	0.187^**	0.040	0.252^†
95% CI	0.165–0.316	0.201–0.351	0.111–0.259	0.111–0.262	−0.036–0.117	0.173–0.330

95% CIs presented are for each individual treatment (not versus placebo MDI)
^**p ≤ 0.01, ^***p ≤ 0.001, ^†p ≤ 0.0001 compared with placebo MDI
^aHighest value of FEV₁ post-dose on Day 1 minus baseline, where baseline = average of FEV₁ pre-dose values across Day 1 of each treatment period
^bNo pairs
^cMean of 1 and 2 h post-dose on Day 1 minus baseline, where baseline = average of IC pre-dose values across Day 1 of each treatment period
BID Twice daily, CI Confidence interval, FEV₁ Forced expiratory volume in 1 s, GP Glycopyrronium, IC Inspiratory capacity, LSM Least squares mean, MDI Metered dose inhaler, mITT Modified intent-to-treat, QID Four times daily

ISSN: 1465-993X