The 24-h FEV1 time profile of olodaterol once daily via Respimat® and formoterol twice daily via Aerolizer® in patients with GOLD 2–4 COPD: results from two 6-week crossover studies

Feldman, Gregory J; Bernstein, Jonathan A; Hamilton, Alan; Nivens, Michael C; Korducki, Lawrence; LaForce, Craig

doi:10.1186/2193-1801-3-419

SpringerPlus

Table 4 Adjusted mean FEV ₁ AUC _0–3 , peak FEV ₁ , and trough FEV ₁ responses (L) compared to placebo after 6 weeks

From: The 24-h FEV₁ time profile of olodaterol once daily via Respimat® and formoterol twice daily via Aerolizer® in patients with GOLD 2–4 COPD: results from two 6-week crossover studies

	Treatment		Adjusted^amean (95% CI) difference from placebo at 6 weeks
*FEV* ₁ *AUC* _0–3	n	Adjusted mean (SE)	Mean (SE)	P value	95% CI
Study 1222.24
Placebo	93	−0.030 (0.020)
Olodaterol 5 μg QD	92	0.134 (0.021)	0.164 (0.019)	< .0001	0.126, 0.201
Olodaterol 10 μg QD	91	0.135 (0.021)	0.164 (0.019)	< .0001	0.127, 0.202
Formoterol 12 μg BID	90	0.168 (0.021)	0.198 (0.019)	< .0001	0.160, 0.236
Study 1222.25
Placebo	91	0.004 (0.024)
Olodaterol 5 μg QD	92	0.190 (0.025)	0.186 (0.019)	< .0001	0.149, 0.223
Olodaterol 10 μg QD	90	0.202 (0.025)	0.198 (0.019)	< .0001	0.162, 0.235
Formoterol 12 μg BID	90	0.217 (0.025)	0.213 (0.019)	< .0001	0.176, 0.250
Peak FEV ₁
Study 1222.24
Placebo	93	0.034 (0.022)
Olodaterol 5 μg QD	92	0.208 (0.022)	0.174 (0.020)	< .0001	0.135, 0.214
Olodaterol 10 μg QD	91	0.200 (0.022)	0.166 (0.020)	< .0001	0.127, 0.206
Formoterol 12 μg BID	90	0.251 (0.022)	0.218 (0.020)	< .0001	0.178, 0.257
Study 1222.25
Placebo	91	0.076 (0.026)
Olodaterol 5 μg QD	92	0.268 (0.026)	0.192 (0.019)	< .0001	0.154, 0.230
Olodaterol 10 μg QD	90	0.273 (0.026)	0.197 (0.020)	< .0001	0.158, 0.235
Formoterol 12 μg BID	90	0.293 (0.026)	0.217 (0.020)	< .0001	0.178, 0.255
Trough FEV ₁
Study 1222.24
Placebo	93	−0.093 (0.023)
Olodaterol 5 μg QD	92	0.012 (0.024)	0.106 (0.021)	< .0001	0.064, 0.147
Olodaterol 10 μg QD	91	0.020 (0.024)	0.113 (0.021)	< .0001	0.072, 0.155
Formoterol 12 μg BID	90	0.040 (0.024)	0.133 (0.021)	< .0001	0.092, 0.175
Study 1222.25
Placebo	91	0.012 (0.030)
Olodaterol 5 μg QD	92	0.109 (0.030)	0.097 (0.026)	.0003	0.045, 0.148
Olodaterol 10 μg QD	90	0.115 (0.030)	0.103 (0.026)	.0001	0.051, 0.155
Formoterol 12 μg BID	90	0.093 (0.030)	0.080 (0.026)	.0026	0.028, 0.132

AUC_0–3 = area under the curve from 0 to 3 h; BID = twice daily; FEV₁ = forced expiratory volume in 1 sec; QD = once daily; SE = standard error.
^aBased on a mixed effects repeated measures model. The model includes treatment and period as fixed effects and center and patient within center as random effects, along with compound symmetry as a covariance structure for within−patient variation.

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