| Literature DB >> 28826397 |
Colin Reisner1, Leonardo M Fabbri2, Edward M Kerwin3, Charles Fogarty4, Selwyn Spangenthal5, Klaus F Rabe6,7, Gary T Ferguson8, Fernando J Martinez9, James F Donohue10, Patrick Darken11, Earl St Rose11, Chad Orevillo11, Shannon Strom12, Tracy Fischer12, Michael Golden12, Sarvajna Dwivedi13.
Abstract
Entities:
Year: 2017 PMID: 28826397 PMCID: PMC5563904 DOI: 10.1186/s12931-017-0638-2
Source DB: PubMed Journal: Respir Res ISSN: 1465-9921
FEV1 AUC0–12 at Day 7: GFF MDI 72/9.6 μg and 36/9.6 μg comparisons (mITT population)
| LSM treatment differences for GFF MDI in FEV1 AUC0–12 at Day 7 | ||||||||
|---|---|---|---|---|---|---|---|---|
| GFF MDI | GP MDI 36 μg | Open-label tiotropium 18 μg | FF MDI | Placebo MDI | Open-label FFa DPI 12 μg | |||
| Comparator | 72/9.6 μg | 36/9.6 μg | 9.6 μg | 7.2 μg | ||||
| GFF MDI 72/9.6 μg | ||||||||
| LSMb difference (SE), L 95% CI | NA | 0.008 (0.0236)–0.039, 0.054c | 0.109 (0.0250)†0.059, 0.158 | 0.103 (0.0216)†0.060, 0.145 | 0.116 (0.0245)†0.068, 0.165 | 0.124 (0.0237)†0.078, 0.171 | 0.298 (0.0261)†0.247, 0.349 | 0.101 (0.0241)†0.053, 0.148 |
| GFF MDI 36/9.6 μg | ||||||||
| LSMb difference (SE), L 95% CI | See above | NA | 0.101 (0.0245)†0.053, 0.149 | 0.095 (0.0213)†0.053, 0.137 | 0.109 (0.0242)†0.061, 0.156 | 0.116 (0.0236)†0.070, 0.163 | 0.290 (0.0261)†0.239, 0.342 | 0.093 (0.0241)***0.045, 0.140 |
*** p < 0.001; † p < 0.0001
aForadil® Aerolizer®; bLSM allows for any imbalances in baseline covariates that relate to responses to be adjusted for in order to avoid bias in treatment effect estimates; cnon-inferiority comparison
CI, confidence interval; DPI, dry powder inhaler; FEV1 AUC0–12, forced expiratory volume in 1 s area under the curve from 0 to 12 h post-dose; FF, formoterol fumarate; GFF, glycopyrrolate/formoterol fumarate; GP, glycopyrrolate; LSM, least squares mean; MDI, metered dose inhaler; mITT, modified intent-to-treat; NA, not available; SE, standard error
Fig. 3Ratio of geometric LSMs and 90% CIs. (a) GFF MDI 36/9.6 μg versus GP MDI 36 μg (b) GFF MDI 36/9.6 μg versus FF MDI 9.6 μg (c) FF MDI 9.6 μg versus FF DPI (PK-mITT population). aLSM allows for any imbalances in baseline covariates that relate to responses to be adjusted for in order to avoid bias in treatment effect estimates. bForadil® Aerolizer®.AUC0–inf, area under the curve from time 0 to infinity; AUC0–12, area under the curve from 0 to 12 h post-dose; CI, confidence interval; Cmax, maximum observed plasma concentration; DPI, dry powder inhaler; FF, formoterol fumarate; GFF, glycopyrrolate/formoterol fumarate; GP, glycopyrrolate; LSM, least squares mean; MDI, metered dose inhaler; PK-mITT, pharmacokinetic modified intent-to-treat