Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease

Table 2 Mean peak change from baseline FEV ₁ (L) by treatment compared with placebo (mITT population)

	PBO MDI	GP MDI 14.4 μg	GP MDI 28.8 μg	GP MDI 57.6 μg	GP MDI 115.2 μg	TIO 18 μg
Peak Change	0.182	0.328	0.340	0.362	0.430	0.380
Comparison vs PBO
Contrast Difference^a	N/A	0.146	0.158	0.180	0.248	0.198
SE	N/A	0.040	0.039	0.039	0.040	0.040
90% CI	N/A	0.066, 0.225	0.081, 0.235	0.103, 0.257	0.168, 0.327	0.119, 0.278
P ^b	N/A	<0.001	<0.001	<0.001	<0.001	<0.001

^aContrast difference [Treatment 1-Treatment 2]; ^b P from mixed-model analysis of variance.
CI = confidence interval; FEV₁ = forced expiratory volume in 1 second; GP MDI = glycopyrronium metered-dose inhaler; L = liters; mITT = modified intent-to-treat; N/A = not applicable; PBO MDI = placebo metered-dose inhaler; SE = standard error; TIO = tiotropium.

ISSN: 1471-2466