Table 1.
A summary of the studies involving umeclidinium.
| Study | Trial design | Subjects | Study duration | Study drug | Outcomes |
|---|---|---|---|---|---|
| Trivedi et al.34 | Randomized placebo-controlled | 168 | 12 weeks | Umec 62.5 µg and 125 µg | Both doses improved trough FEV1 by 127 ml and 152 ml respectively, significant SGRQ improvement compared to placebo for both doses, significant improvement in TDI for Umec 125 µg |
| Donohue et al.37 | Randomized double-blind placebo-controlled | 562 | 52 weeks | Umec/Vil 125/25 µg, Umec 125 µg, or placebo |
Incidents of on-treatment AEs, serious AEs and drug-related AEs was similar between groups, incidents of atrial arrhythmias were similar between groups, both active treatment improved lung functions compared to placebo |
| Celli et al.41 | Double-blind placebo-controlled parallel-group | 1493 | 24 weeks | Umec/Vil 125/25 µg, Umec 125 µg, Vil 25 µg, or placebo | All active treatments improved trough FEV1 compared to placebo, improvements for Umec/Vil 125/25 µg versus placebo were observed for the TDI, rescue albuterol use at weeks 1–24 and SGRQ |
| Donohue et al.43 | Double-blind placebo-controlled parallel-group | 532 | 4 weeks | Umec/Vil 62.5/25 µg, Umec 62.5 µg, Vil 25 µg or placebo | All active treatments improved FEV1 compared to placebo, increases with Umec/Vil 62.5/25 µg were significantly greater than monotherapies |
| Decramer et al.37 | Randomized blinded double-dummy parallel-group | 1141 | 24 weeks | Umec/Vil 125/5 µg, Umec/Vil 62.5/25 µg, Tio 18 µg, and either Vil 25 µg (study 1) or Umec 125 µg (study 2) | FEV1 improved in both studies on day 169 compared to Tio monotherapy, both doses of Umec/Vil improved FEV1 compared to Vil alone, all treatments produced improvement in dyspnoea and health-related quality of life |
| Maleki- Yazdi et al.44 | Randomized blinded double-dummy parallel-group | 1191 | 24 weeks | Umec/Vil 62.5/25 µg versus Tio 18 µg | A significant improvement in FEV1 in favour of Umec/Vil compared to Tio, Umec/Vil improved SGRQ and reduced the need for rescue medication compared to Tio |
AE, adverse events; FEV1, forced expiratory volume in 1 s; ml, millilitres; SGRQ, St. George’s respiratory questionnaire; TDI, transitional dyspnoea index; Tio, tiotropium; Umec, umeclidinium; Vil, vilanterol.