Cargando…

Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study

ABSTRACT: Indacaterol (IND; 150 μg), glycopyrronium (GLY; 50 μg) and mometasone furoate (MF; 160 μg [high-dose ICS] and 80 μg [medium-dose ICS]) have been formulated as a once-daily (o.d.) fixed-dose combination treatment delivered via the Breezhaler® device for the treatment of patients with asthma...

Descripción completa

Detalles Bibliográficos
Autores principales: Watz, Henrik, Hohlfeld, Jens M., Singh, Dave, Beier, Jutta, Diamant, Zuzana, Liu, Jinming, Hua, Shucheng, Abd-Elaziz, Khalid, Pinot, Pascale, Jones, Ieuan, Tillmann, Hanns-Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160900/
https://www.ncbi.nlm.nih.gov/pubmed/32295593
http://dx.doi.org/10.1186/s12931-020-01349-5
_version_ 1783522844494266368
author Watz, Henrik
Hohlfeld, Jens M.
Singh, Dave
Beier, Jutta
Diamant, Zuzana
Liu, Jinming
Hua, Shucheng
Abd-Elaziz, Khalid
Pinot, Pascale
Jones, Ieuan
Tillmann, Hanns-Christian
author_facet Watz, Henrik
Hohlfeld, Jens M.
Singh, Dave
Beier, Jutta
Diamant, Zuzana
Liu, Jinming
Hua, Shucheng
Abd-Elaziz, Khalid
Pinot, Pascale
Jones, Ieuan
Tillmann, Hanns-Christian
author_sort Watz, Henrik
collection PubMed
description ABSTRACT: Indacaterol (IND; 150 μg), glycopyrronium (GLY; 50 μg) and mometasone furoate (MF; 160 μg [high-dose ICS] and 80 μg [medium-dose ICS]) have been formulated as a once-daily (o.d.) fixed-dose combination treatment delivered via the Breezhaler® device for the treatment of patients with asthma. In this randomized (n = 116), double-blind, double-dummy, active comparator-controlled, three-period cross-over study we evaluated the benefit of o.d. IND/GLY/MF versus twice daily (b.i.d.) salmeterol/fluticasone propionate combination (SFC; 50/500 μg; high-dose ICS) treatment (NCT03063086). Overall, 107 patients completed the study. The study met its primary objective by demonstrating superiority of o.d. IND/GLY/MF at medium and high-dose ICS over b.i.d. SFC (high-dose ICS) in peak FEV(1) after 21 days of treatment (+ 172 mL with high-dose and + 159 mL with medium-dose IND/GLY/MF versus SFC, p < 0.0001 for each comparison). We also observed that a higher percentage of patients did not need rescue medicine with IND/GLY/MF (high-dose ICS, 58%; medium-dose ICS, 52%) compared with SFC (45%) during the last week of each treatment period. Study treatments were well-tolerated with no relevant differences in tolerability between both IND/GLY/MF doses and SFC. In conclusion, both doses of IND/GLY/MF provided superior lung function benefits compared with twice-daily, standard-of-care SFC at the highest approved dose. TRIAL REGISTRATION: ClinicalTrials.gov, (Identifier: NCT03063086), EudraCT start date: May 11, 2017; First patient first visit / study initiation date: May 31, 2017.
format Online
Article
Text
id pubmed-7160900
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-71609002020-04-21 Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study Watz, Henrik Hohlfeld, Jens M. Singh, Dave Beier, Jutta Diamant, Zuzana Liu, Jinming Hua, Shucheng Abd-Elaziz, Khalid Pinot, Pascale Jones, Ieuan Tillmann, Hanns-Christian Respir Res Letter to the Editor ABSTRACT: Indacaterol (IND; 150 μg), glycopyrronium (GLY; 50 μg) and mometasone furoate (MF; 160 μg [high-dose ICS] and 80 μg [medium-dose ICS]) have been formulated as a once-daily (o.d.) fixed-dose combination treatment delivered via the Breezhaler® device for the treatment of patients with asthma. In this randomized (n = 116), double-blind, double-dummy, active comparator-controlled, three-period cross-over study we evaluated the benefit of o.d. IND/GLY/MF versus twice daily (b.i.d.) salmeterol/fluticasone propionate combination (SFC; 50/500 μg; high-dose ICS) treatment (NCT03063086). Overall, 107 patients completed the study. The study met its primary objective by demonstrating superiority of o.d. IND/GLY/MF at medium and high-dose ICS over b.i.d. SFC (high-dose ICS) in peak FEV(1) after 21 days of treatment (+ 172 mL with high-dose and + 159 mL with medium-dose IND/GLY/MF versus SFC, p < 0.0001 for each comparison). We also observed that a higher percentage of patients did not need rescue medicine with IND/GLY/MF (high-dose ICS, 58%; medium-dose ICS, 52%) compared with SFC (45%) during the last week of each treatment period. Study treatments were well-tolerated with no relevant differences in tolerability between both IND/GLY/MF doses and SFC. In conclusion, both doses of IND/GLY/MF provided superior lung function benefits compared with twice-daily, standard-of-care SFC at the highest approved dose. TRIAL REGISTRATION: ClinicalTrials.gov, (Identifier: NCT03063086), EudraCT start date: May 11, 2017; First patient first visit / study initiation date: May 31, 2017. BioMed Central 2020-04-15 2020 /pmc/articles/PMC7160900/ /pubmed/32295593 http://dx.doi.org/10.1186/s12931-020-01349-5 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.
spellingShingle Letter to the Editor
Watz, Henrik
Hohlfeld, Jens M.
Singh, Dave
Beier, Jutta
Diamant, Zuzana
Liu, Jinming
Hua, Shucheng
Abd-Elaziz, Khalid
Pinot, Pascale
Jones, Ieuan
Tillmann, Hanns-Christian
Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study
title Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study
title_full Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study
title_fullStr Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study
title_full_unstemmed Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study
title_short Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study
title_sort letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study
topic Letter to the Editor
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160900/
https://www.ncbi.nlm.nih.gov/pubmed/32295593
http://dx.doi.org/10.1186/s12931-020-01349-5
work_keys_str_mv AT watzhenrik lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy
AT hohlfeldjensm lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy
AT singhdave lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy
AT beierjutta lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy
AT diamantzuzana lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy
AT liujinming lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy
AT huashucheng lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy
AT abdelazizkhalid lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy
AT pinotpascale lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy
AT jonesieuan lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy
AT tillmannhannschristian lettertotheeditorindacaterolglycopyrroniummometasonefuroatecomparedwithsalmeterolfluticasonepropionateinpatientswithasthmaarandomizedcontrolledcrossoverstudy