Table 2.
Phase III pivotal studies
| Study | Design | No of patients | Treatments | Results |
|---|---|---|---|---|
| Ferguson et al17 | Two replicate, randomized, double-blind, placebo-controlled, parallel-group, trials | 1,266 (624+642) | Olodaterol SMI 5 or 10 μg QD for 48 weeks | Significant improvement in FEV1 AUC0–3 and trough FEV1 at week 12 (5 μg, 0.172 and 0.176 L; 10 μg, 0.091 and 0.101 L) and week 48 (5 μg, 0.173 and 0.169 L; 10 μg, 0.092 and 0.091 L) Daytime rescue medication use reduced for both olodaterol doses (5 μg, −0.46; 10 μg, −0.57 actuations/day) Nighttime rescue medication use reduced for both olodaterol doses (5 μg, −0.50; 10 μg, −0.78 actuations/day) PGR scores, statistically significantly improved versus placebo with both olodaterol doses |
| Koch et al18 | Two replicate, randomized, double-blind, placebo-controlled, parallel-group, trials | 1,838 (904+934) | Olodaterol SMI 5 and 10 μg QD and formoterol 12 μg BID for 48 weeks | In both trials at week 24, significant improvement in FEV1 AUC0–3 (5 μg, 0.151 and 0.129 L; 10 μg, 0.165 and 0.154 L; formoterol, 0.177 and 0.150 L) and trough FEV1 (5 μg, 0.078 and 0.053 L; 10 μg, 0.085 and 0.069 L; formoterol, 0.054 and 0.042 L) versus placebo No statistically significant differences in TDI focal score for any of the active therapies versus placebo at week 24 Improvement in SGRQ total score for 5 μg (−2.8) and 10 μg (−3.4), but not formoterol (−1.2) compared to placebo at week 24 Significant reductions in weekly mean daytime and nighttime rescue medication compared to placebo throughout the 48-week treatment period |
| Feldman et al19 | Two replicate, multicenter, randomized, double-blind, double-dummy, placebo-controlled, four-way crossover studies | 199 (99+100) | Olodaterol SMI 5 and 10 μg QD and formoterol 12 μg BID for 6 weeks in addition to usual-care background maintenance therapy | No differences between 5 and 10 μg for the FEV1 AUC0–12 and FEV1 AUC12–24 response No differences between 5 and 10 μg compared to formoterol for the FEV1 AUC0–12 response and FEV1 AUC12–24 response for formoterol greater than 5 and 10 μg No differences in peak FEV1 responses between 5 and 10 μg, but peak FEV1 response for both 5 and 10 μg lower than formoterol (−0.036 and −0.034 L, respectively) |
| Lange et al20 | Two replicate, randomized, double-blind, four-way crossover, active- and placebo-controlled trials | 230 (108+122) | Olodaterol SMI 5 and 10 μg QD and tiotropium 18 μg QD via the HandiHaler for 6 weeks | In both trials at week 6, significant improvement in FEV1 AUC0–3 (5 μg, 0.206 and 0.214 L; 10 μg, 0.215 and 0.245 L; tiotropium, 0.182 and 0.235 L), FEV1 AUC0–12 (5 μg, 0.185 and 0.197 L; 10 μg, 0.207 and 0.197 L; tiotropium, 0.173 and 0.221 L), FEV1 AUC12–24 (5 μg, 0.131 and 0.153 L; 10 μg, 0.178 and 0.170 L; tiotropium, 0.123 and 0.164 L), and trough FEV1 (5 μg, 0.133 and 0.134 L; 10 μg, 0.147 and 0.143 L; tiotropium, 0.097 and 0.158 L) versus placebo |
Abbreviations: QD, once daily; BID, twice daily; FEV1, forced expiratory volume in 1 second; AUC0–3, area under the curve from 0 to 3 hours; PGR, Patient Global Rating; TDI, transition dyspnea index; SGRQ, St George’s Respiratory Questionnaire; SMI, Soft Mist inhaler.