Open Access

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 Reisner1Email author,
  • Leonardo M. Fabbri2,
  • Edward M. Kerwin3,
  • Charles Fogarty4,
  • Selwyn Spangenthal5,
  • Klaus F. Rabe6, 7,
  • Gary T. Ferguson8,
  • Fernando J. Martinez9,
  • James F. Donohue10,
  • Patrick Darken1,
  • Earl St. Rose1,
  • Chad Orevillo1,
  • Shannon Strom11,
  • Tracy Fischer11,
  • Michael Golden11 and
  • Sarvajna Dwivedi12
Respiratory Research201718:158

https://doi.org/10.1186/s12931-017-0638-2

Received: 7 August 2017

Accepted: 7 August 2017

Published: 21 August 2017

The original article was published in Respiratory Research 2017 18:8

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

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.
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

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.

Notes

Declarations

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.

Authors’ Affiliations

(1)
Pearl Therapeutics Inc.
(2)
Department of Medicine
(3)
Clinical Research Institute of Southern Oregon
(4)
Spartanburg Medical Research
(5)
American Health Research
(6)
Lungen Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research (DZL)
(7)
Department of Medicine, Christian-Albrechts University Kiel
(8)
Pulmonary Research Institute of Southeast Michigan
(9)
Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medical College; New York-Presbyterian Hospital/Weill Cornell MedicalCenter
(10)
Department of Medicine, University of North Carolina School of Medicine
(11)
Pearl Therapeutics Inc.
(12)
Pearl Therapeutics Inc.

Reference

  1. Reisner C, Fabbri LM, Kerwin EM, Fogarty C, Spangenthal S, Rabe KF, Ferguson GT, Martinez FJ, Donohue JF, Darken P, Rose ES. 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. Respir Res. 2017 Jan 6;18(1):8.View ArticlePubMedPubMed CentralGoogle Scholar

Copyright

© The Author(s). 2017

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