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Forced Expiratory Flow (FEF(25–75%)) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis
INTRODUCTION: In pediatric patients with asthma, measurements of forced expiratory volume in 1 s (FEV(1)) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25–75% of the vital capacity (FEF(25–75%)) is a potentially more sensitive parameter for assessing peripheral...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7672130/ https://www.ncbi.nlm.nih.gov/pubmed/32399899 http://dx.doi.org/10.1007/s41030-020-00117-6 |
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author | Szefler, Stanley J. Goldstein, Stanley Vogelberg, Christian Bensch, George W. Given, John Jugovic, Branko Engel, Michael Moroni-Zentgraf, Petra M. Sigmund, Ralf Hamelmann, Eckard H. |
author_facet | Szefler, Stanley J. Goldstein, Stanley Vogelberg, Christian Bensch, George W. Given, John Jugovic, Branko Engel, Michael Moroni-Zentgraf, Petra M. Sigmund, Ralf Hamelmann, Eckard H. |
author_sort | Szefler, Stanley J. |
collection | PubMed |
description | INTRODUCTION: In pediatric patients with asthma, measurements of forced expiratory volume in 1 s (FEV(1)) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25–75% of the vital capacity (FEF(25–75%)) is a potentially more sensitive parameter for assessing peripheral airway function. This post hoc analysis compared FEF(25–75%) with FEV(1) as an endpoint to assess bronchodilator responsiveness in children with asthma. METHODS: Change from baseline in trough FEF(25–75%) and trough FEV(1) following treatment with either tiotropium (5 µg or 2.5 µg) or placebo Respimat(®) was analyzed in four phase III trials in children (aged 6–11 years) and adolescents (aged 12–17 years) with symptomatic moderate (VivaTinA-asthma(®) and PensieTinA-asthma(®)) and mild (CanoTinA-asthma(®) and RubaTinA-asthma(®)) asthma. Data from all treatment arms were pooled and correlations between FEF(25–75%) and FEV(1) were calculated and analyzed. RESULTS: A total of 1590 patients were included in the analysis. Tiotropium Respimat(®) consistently improved FEF(25–75%) and FEV(1) versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant. Improvements in FEF(25–75%) response with tiotropium versus placebo were largely more pronounced than improvements in FEV(1). Statistical assessment of the correlation of FEV(1) and FEF(25–75%) showed moderate-to-high correlations (Pearson’s correlation coefficients 0.73–0.80). CONCLUSIONS: In pediatric patients, FEF(25–75%) may be a more sensitive measure to detect treatment response, certainly to tiotropium, than FEV(1) and should be evaluated as an additional lung function measurement. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s41030-020-00117-6) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-7672130 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-76721302020-11-20 Forced Expiratory Flow (FEF(25–75%)) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis Szefler, Stanley J. Goldstein, Stanley Vogelberg, Christian Bensch, George W. Given, John Jugovic, Branko Engel, Michael Moroni-Zentgraf, Petra M. Sigmund, Ralf Hamelmann, Eckard H. Pulm Ther Commentary INTRODUCTION: In pediatric patients with asthma, measurements of forced expiratory volume in 1 s (FEV(1)) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25–75% of the vital capacity (FEF(25–75%)) is a potentially more sensitive parameter for assessing peripheral airway function. This post hoc analysis compared FEF(25–75%) with FEV(1) as an endpoint to assess bronchodilator responsiveness in children with asthma. METHODS: Change from baseline in trough FEF(25–75%) and trough FEV(1) following treatment with either tiotropium (5 µg or 2.5 µg) or placebo Respimat(®) was analyzed in four phase III trials in children (aged 6–11 years) and adolescents (aged 12–17 years) with symptomatic moderate (VivaTinA-asthma(®) and PensieTinA-asthma(®)) and mild (CanoTinA-asthma(®) and RubaTinA-asthma(®)) asthma. Data from all treatment arms were pooled and correlations between FEF(25–75%) and FEV(1) were calculated and analyzed. RESULTS: A total of 1590 patients were included in the analysis. Tiotropium Respimat(®) consistently improved FEF(25–75%) and FEV(1) versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant. Improvements in FEF(25–75%) response with tiotropium versus placebo were largely more pronounced than improvements in FEV(1). Statistical assessment of the correlation of FEV(1) and FEF(25–75%) showed moderate-to-high correlations (Pearson’s correlation coefficients 0.73–0.80). CONCLUSIONS: In pediatric patients, FEF(25–75%) may be a more sensitive measure to detect treatment response, certainly to tiotropium, than FEV(1) and should be evaluated as an additional lung function measurement. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s41030-020-00117-6) contains supplementary material, which is available to authorized users. Springer Healthcare 2020-05-12 /pmc/articles/PMC7672130/ /pubmed/32399899 http://dx.doi.org/10.1007/s41030-020-00117-6 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial 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, visithttp://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Commentary Szefler, Stanley J. Goldstein, Stanley Vogelberg, Christian Bensch, George W. Given, John Jugovic, Branko Engel, Michael Moroni-Zentgraf, Petra M. Sigmund, Ralf Hamelmann, Eckard H. Forced Expiratory Flow (FEF(25–75%)) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
title | Forced Expiratory Flow (FEF(25–75%)) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
title_full | Forced Expiratory Flow (FEF(25–75%)) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
title_fullStr | Forced Expiratory Flow (FEF(25–75%)) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
title_full_unstemmed | Forced Expiratory Flow (FEF(25–75%)) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
title_short | Forced Expiratory Flow (FEF(25–75%)) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
title_sort | forced expiratory flow (fef(25–75%)) as a clinical endpoint in children and adolescents with symptomatic asthma receiving tiotropium: a post hoc analysis |
topic | Commentary |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7672130/ https://www.ncbi.nlm.nih.gov/pubmed/32399899 http://dx.doi.org/10.1007/s41030-020-00117-6 |
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