Literature DB >> 28826397

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.

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


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Erratum

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
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 MDIGP MDI 36 μgOpen-label tiotropium 18 μgFF MDIPlacebo MDIOpen-label FFa DPI 12 μg
Comparator72/9.6 μg36/9.6 μg9.6 μg7.2 μg
GFF MDI 72/9.6 μg
 LSMb difference (SE), L 95% CINA0.008 (0.0236)–0.039, 0.054c 0.109 (0.0250)0.059, 0.1580.103 (0.0216)0.060, 0.1450.116 (0.0245)0.068, 0.1650.124 (0.0237)0.078, 0.1710.298 (0.0261)0.247, 0.3490.101 (0.0241)0.053, 0.148
GFF MDI 36/9.6 μg
 LSMb difference (SE), L 95% CISee aboveNA0.101 (0.0245)0.053, 0.1490.095 (0.0213)0.053, 0.1370.109 (0.0242)0.061, 0.1560.116 (0.0236)0.070, 0.1630.290 (0.0261)0.239, 0.3420.093 (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. 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

The first sentence in the subsection “Baseline characteristics” originally read: Patients’ baseline and demographic characteristics are shown in Table 1 (mITT population). 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. FEV1 AUC0–12 at Day 7: GFF MDI 72/9.6 μg and 36/9.6 μg comparisons (mITT population) *** 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 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. 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.
  1 in total

1.  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.

Authors:  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
Journal:  Respir Res       Date:  2017-01-06
  1 in total

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