Table 1.

Phase II pivotal studies

Study	Design	No of patients	Treatments	Results
van Noord et al14	Single-center, double-blind, placebo-controlled, five-way crossover study	36	Olodaterol SMI 2, 5, 10, or 20 μg	All olodaterol doses superior to placebo for trough FEV1, peak FEV1 (0.121–0.213 L), and average FEV1 both during the daytime (0–12 h; ranging from 0.099 to 0.184 L) and nighttime (12–24 h; ranging from 0.074 to 0.141 L)
Maleki-Yazdi et al15	Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study	405	Olodaterol SMI 2, 5, 10, or 20 μg QD for 4 weeks	All olodaterol doses superior to placebo for trough FEV1 versus placebo (2 μg, 0.061 L; 5 μg, 0.097 L; 10 μg, 0.123 L; 20 μg, 0.132 L) The two highest doses (10 and 20 μg) formed the plateau of the dose–response curve
Joos et al16	Randomized, double-blind, four-way, crossover, study	47	Olodaterol SMI 2 μg BID, 5 μg BID, 5 μg QD, and 10 μg QD for 3 weeks	All olodaterol doses significantly increased FEV1 baseline FEV1 time profiles nearly identical for olodaterol 5 and 10 μg QD Olodaterol 5 μg QD higher FEV1 AUC0–12 and similar AUC12–24 versus 2 μg BID Olodaterol 5 μg QD higher FEV1 AUC0–12 but lower AUC12–24 versus 5 μg BID Bronchodilation over 24 hours similar for olodaterol 5 μg QD and BID

Abbreviations: QD, once daily; BID, twice daily; FEV₁, forced expiratory volume in 1 second; AUC_0–12, area under the curve from 0 to 12 hours; AUC_12–24, area under the curve from 12 to 24 hours; SMI, Soft Mist inhaler; h, hour.