Table 1.
Characteristics of the clinical studies on UMEC/VI
| Reference | Patients | Duration | Treatment arms | Primary endpoint Co-primary endpoint | Results |
|---|---|---|---|---|---|
| Kelleher et al35 | 16 (healthy) | Single dose | UMEC/VI (500/50 μg) UMEC (500) VI (50) Placebo |
Safety | No differences of active treatments vs placebo |
| Kelleher et al36 | 103 (healthy) | 28 days | UMEC/VI (125/25 μg) UMEC/VI (500/100 μg) UMEC (500 μg) Moxifloxacin* Placebo |
Safety | No differences of active treatments vs placebo |
| Feldman et al40 | 51 (COPD) | 28 days | UMEC/VI (500/25 μg) n=42 Placebo n=9 |
Weighted mean pulse rate over 0–6 hours at day 28 | Weighted mean pulse rate: UMEC/VI was non inferior to placebo FEV1 mean change from baseline 163 mL vs 9 mL (active vs placebo) |
| Donohue et al41 | 1532 (COPD) | 24 weeks | UMEC/VI (62.5/25 μg) n=413 UMEC (62.5 μg) n=412 VI (25 μg) n=418 Placebo n=208 |
Trough FEV1 at day 169 (Week 24) 0 to 6 hours weighted mean FEV1 at day 168 |
All active improved FEV1 vs placebo Improvement RM, TDI, HRQLQ combined treatment compared to placebo |
| Celli et al42 | 1493 (COPD) | 24 weeks | UMEC/VI (125/25 μg) n=403 UMEC (125 μg) n=407 VI (25 μg) n=404 Placebo n=275 |
Trough FEV1 at day 169 (Week 24) 0 to 6 hours weighted mean FEV1 at day 168 |
All active improved FEV1 vs placebo Improvement RM, TDI, HRQLQ combined treatment compared to placebo |
| Anzueto et al43 | 843 (COPD) | 24 weeks | UMEC/VI (125/25 μg) n=214 UMEC/VI (62.5/25 μg) n=212 VI (25 μg) n=208 TIO (18 μg) n=207 |
Trough FEV1 at day 169 (Week 24) 0 to 6 hours weighted mean FEV1 at day 168 |
Improvements in least squares mean change from baseline FEV1 and 0–6 hours weighted mean FEV1 both combination treatments compared with the monotherapies |
| NCT0131691344 | 869 (COPD) | 24 weeks | UMEC/VI (125/25 μg) n=215 UMEC/VI (62.5/25 μg) n=217 UMEC (125 μg) n=222 TIO (18 μg) n=215 |
Trough FEV1 at day 169 (Week 24) 0 to 6 hours weighted mean FEV1 at day 168 |
UMEC/VI (both doses) improved FEV1 vs TIO |
Note:
*
Treatment arms description not provided.
Abbreviations: COPD, chronic obstructive pulmonary disease; UMEC, umeclidinium; VI, vilanterol; TIO, tiotropium; FEV1, forced expiratory volume at the first second; RM, rescue medication; TDI, transient dyspnea index; HRQLQ, health related quality of life questionnaire.