Erratum to: A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease
verfasst von:
Colin Reisner, Leonardo M. Fabbri, Edward M. Kerwin, Charles Fogarty, Selwyn Spangenthal, Klaus F. Rabe, Gary T. Ferguson, Fernando J. Martinez, James F. Donohue, Patrick Darken, Earl St. Rose, Chad Orevillo, Shannon Strom, Tracy Fischer, Michael Golden, Sarvajna Dwivedi
Upon Publication of the original article [1] several discrepancies were highlighted in the following sections; Results, Table 1, Table 2 and Fig. 3. These errors have since been acknowledged and corrected in this erratum
The first sentence in the subsection “Baseline characteristics” originally read: Patients’ baseline and demographic characteristics are shown in Table 1 (mITT population).
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This should read: Patients’ baseline and demographic characteristics are shown in Table 1.
The header of Table 1 read: Baseline demographics (mITT population)
This should read as: Baseline demographics (ITT population)
It was noticed that Table 2 contained an error. In Table 2, data row 2, the footnote symbol ‘c’ was erroneously included in the third column. The footnote symbol ‘c ‘should be placed in the second column in this row. The corrected Table 2 is shown below.
Table 2
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
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It was noticed that in Fig. 3b, the error bar on the 4th data point (AUCinf) was incorrectly given. The error bar on the 4th data point (AUCinf) should range from 74.88, to 103.28 The corrected Fig. 3b is shown below.
Fig. 3
Ratio 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
×
These corrections do not change the conclusions of the article.
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Erratum to: A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease
verfasst von
Colin Reisner Leonardo M. Fabbri Edward M. Kerwin Charles Fogarty Selwyn Spangenthal Klaus F. Rabe Gary T. Ferguson Fernando J. Martinez James F. Donohue Patrick Darken Earl St. Rose Chad Orevillo Shannon Strom Tracy Fischer Michael Golden Sarvajna Dwivedi
