UMEC | GLYCO | Difference UMEC versus GLYCO (95% CI)# | |
Intent-to-treat population n | 516 | 518 | |
Trough FEV1¶ day 85 | |||
Patients with analysable data | 486 | 481 | |
Change from baseline mL | 126±10 | 93±10 | 33 (5–61) |
Trough FVC¶ day 85 | |||
Patients with analysable data | 486 | 481 | |
Change from baseline mL | 157±16 | 143±16 | 14 (−31–59) |
24H population n | 166 | 168 | |
Weighted mean FEV1 0–24 h+ day 1 | |||
Patients with analysable data | 166 | 166 | |
Change from baseline mL | 61±12 | 84±12 | −23 (−57–10) |
Weighted mean FEV1 0–24 h+ day 84 | |||
Patients with analysable data | 155 | 159 | |
Change from baseline mL | 62±18 | 67±17 | −5 (−54–44) |
Data are presented as least-square mean±se, or n, unless otherwise stated. #: no inferences can be made from the above comparisons because this was a lung-function endpoint and the superiority criterion was not reached; ¶: analysis performed using a repeated measures model with covariates of treatment, baseline forced expiratory volume in 1 s (FEV1) or forced vital capacity (FVC) (mean of the values measured at 30 min and 5 min pre-dose on day 1), centre group, 24H subset flag, day, day by baseline and day by treatment interactions; +: analysis performed using a mixed-model repeated measures model including covariates of baseline FEV1, centre group, 24H subset flag, day, treatment, day by baseline interaction and day by treatment interaction; 24H: subset of patients who completed 24-h spirometry on day 1 and day 84; GLYCO: glycopyrronium; UMEC: umeclidinium.