Comparator | Treatment differences for GFF MDI comparisons | |||||
---|---|---|---|---|---|---|
GP MDI 36 μg | Open-label tiotropium 18 μg | FF MDI | Placebo MDI | Open-label FFa DPI 12 μg | ||
9.6 μg | 7.2 μg | |||||
DAY 7 | ||||||
Change from baseline in morning pre-dose trough FEV1, L | ||||||
GFF MDI 72/9.6 μg | ||||||
LSMb difference (SE) | 0.0960 (0.0280)*** | 0.096 (0.0247)† | 0.129 (0.0278)† | 0.120 (0.0271)† | 0.234 (0.0302)† | 0.091 (0.0277)** |
GFF MDI 36/9.6 μg | ||||||
LSMb difference (SE) | 0.073 (0.0273)** | 0.073 (0.0245)** | 0.106 (0.0274)† | 0.097 (0.0270)*** | 0.211 (0.0300)† | 0.068 (0.0275)* |
Peak change from baseline in FEV1, L | ||||||
GFF MDI 72/9.6 μg | ||||||
LSMb difference (SE) | 0.125 (0.0282)† | 0.140 (0.0248)† | 0.101 (0.0279)*** | 0.108 (0.0271)† | 0.342 (0.0300)† | 0.082 (0.0278)** |
GFF MDI 36/9.6 μg | ||||||
LSMb difference (SE) | 0.127 (0.0273)† | 0.141 (0.0245)† | 0.103 (0.0273)*** | 0.110 (0.0268)† | 0.344 (0.0298)† | 0.083 (0.0276)** |
Change from baseline in morning pre-dose trough IC, L | ||||||
GFF MDI 72/9.6 μg | ||||||
LSMb difference (SE) | 0.083 (0.0445) | 0.090 (0.0399)* | 0.156 (0.0452)*** | 0.110 (0.0436)* | 0.255 (0.0483)† | 0.096 (0.0447)* |
GFF MDI 36/9.6 μg | ||||||
LSMb difference (SE) | 0.098 (0.0445)* | 0.105 (0.0387)** | 0.172 (0.0433)† | 0.126 (0.0428)** | 0.271 (0.0471)† | 0.111 (0.0434)* |
Peak change from baseline in IC, L | ||||||
GFF MDI 72/9.6 μg | ||||||
LSMb difference (SE) | 0.078 (0.0532) | 0.095 (0.0470)* | 0.050 (0.0529) | 0.033 (0.0513) | 0.265 (0.0572)† | 0.016 (0.0527) |
GFF MDI 36/9.6 μg | ||||||
LSMb difference (SE) | 0.107 (0.0513)* | 0.124 (0.0461)** | 0.078 (0.0513) | 0.062 (0.0503) | 0.293 (0.0559)† | 0.045 (0.0518) |
DAY 1 | ||||||
Peak change from baseline in FEV1, L | ||||||
GFF MDI 72/9.6 μg | ||||||
LSMb difference (SE) | 0.081 (0.0309)** | 0.104 (0.0268)† | 0.062 (0.0307)* | 0.060 (0.0297)* | 0.265 (0.0328)† | 0.072 (0.0306)* |
GFF MDI 36/9.6 μg | ||||||
LSMb difference (SE) | 0.068 (0.300)* | 0.090 (0.0266)*** | 0.048 (0.0300) | 0.046 (0.0293) | 0.251 (0.0326)† | 0.058 (0.0303) |
Peak change from baseline in IC, L | ||||||
GFF MDI 72/9.6 μg | ||||||
LSMb difference (SE) | 0.065 (0.0567) | 0.149 (0.0493)** | 0.134 (0.0564)* | 0.144 (0.0547)** | 0.412 (0.0607)† | 0.121 (0.0561)* |
GFF MDI 36/9.6 μg | ||||||
LSMb difference (SE) | −0.019 (0.0555) | 0.065 (0.0491) | 0.050 (0.0554) | 0.060 (0.0542) | 0.328 (0.0602)† | 0.037 (0.0557) |
Time to onset of action, hazard ratioc | ||||||
GFF MDI 72/9.6 μg | ||||||
HR | 1.399* | 1.754*** | 0.980 | 1.150 | 3.475† | 0.971 |
95% CI | 1.038, 1.884 | 1.300, 2.367 | 0.746, 1.289 | 0.904, 1.465 | 2.095, 5.765 | 0.713, 1.321 |
GFF MDI 36/9.6 μg | ||||||
HR | 1.323 | 1.695*** | 0.888 | 1.062 | 3.358† | 0.878 |
95% CI | 0.936, 1.870 | 1.275, 2.253 | 0.671, 1.175 | 0.0806, 1.400 | 2.091, 5.391 | 0.660, 1.169 |