. 2013 Nov 27;54(4):405–414. doi: 10.1002/jcph.215

Table 3.

Clinical Study: FEV₁ Results by Treatment Group

	Treatment group
	Placebo (n = 143)	Solution 1.25 µg (n = 143)	Solution 2.5 µg (n = 144)	Solution 5 µg (n = 143)	Powder 18 µg^b (n = 142)
Day 29 FEV₁ AUC_0–6h (mL)
Adjusted mean (SE)	1,371 (46)	1,535 (46)	1,556 (46)	1,562 (46)	1,567 (46)
Comparison versus placebo^a
Adjusted mean (SE)		165 (12)	185 (12)	191 (12)	196 (12)
95% CI		141, 189	161, 209	167, 216	172, 220
P-value		<.0001^a	<.0001	<.0001	<.0001
Comparison versus powder 18 µg
Adjusted mean (SE)		−31 (12)	−11 (12)	−5 (12)
95% CI		−55, −7	−35, 13	−29, 19
Trough FEV₁ (mL)
Adjusted mean (SE)	1,345 (45)	1,432 (45)	1,446 (45)	1,466 (45)	1,473 (45)
Comparison versus placebo^a
Adjusted mean (SE)		87 (14)	101 (14)	121 (14)	128 (14)
95% CI		60, 114	74, 128	94, 148	101, 155
P-value		<.0001^a	<.0001	<.0001	<.0001
Comparison versus powder 18 µg
Adjusted mean (SE)		−41 (14)	−27 (14)	−7 (14)
95% CI		−68, −14	−55, 0	−34, 20
Day 29 FEV₁ AUC_0–3h (mL)
Adjusted mean (SE)	1,366 (46)	1,521 (46)	1,546 (46)	1,553 (46)	1,558 (46)
Comparison versus placebo^a
Adjusted mean (SE)		155 (13)	180 (13)	187 (13)	191 (13)
95% CI		130, 180	155, 205	162, 211	167, 216
P-value		<.0001^a	<.0001	<.0001	<.0001
Comparison versus powder 18 µg
Adjusted mean (SE)		−36 (13)	−11 (13)	−5 (13)
95% CI		−61, −12	−36, 13	−29, 20

AUC_0–3h, area under the curve from 0 to 3 hours; AUC_0–6h, area under the curve from 0 to 6 hours; CI, confidence interval; FEV₁, forced expiratory volume in 1 second; SE, standard error.

Superiority tests for tiotropium solution 1.25 µg versus placebo were not predefined; in order for tiotropium solution 1.25 µg to be declared an ineffective dose compared to placebo, the 95% CI for the treatment difference had to lie entirely below the prespecified limit of 0.1 L.

Tiotropium powder 18 µg was not blinded.