Forced Expiratory Flow (FEF25–75%) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis
Abstract Introduction In pediatric patients with asthma, measurements of forced expiratory volume in 1 s (FEV1) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25–75% of the vital capacity (FEF25–75%) is a potentially more sensitive parameter for assessing periphe...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Adis, Springer Healthcare
2020-05-01
|
| Series: | Pulmonary Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/s41030-020-00117-6 |
| _version_ | 1818649594563657728 |
|---|---|
| author | Stanley J. Szefler Stanley Goldstein Christian Vogelberg George W. Bensch John Given Branko Jugovic Michael Engel Petra M. Moroni-Zentgraf Ralf Sigmund Eckard H. Hamelmann |
| author_facet | Stanley J. Szefler Stanley Goldstein Christian Vogelberg George W. Bensch John Given Branko Jugovic Michael Engel Petra M. Moroni-Zentgraf Ralf Sigmund Eckard H. Hamelmann |
| author_sort | Stanley J. Szefler |
| collection | DOAJ |
| description | Abstract Introduction In pediatric patients with asthma, measurements of forced expiratory volume in 1 s (FEV1) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25–75% of the vital capacity (FEF25–75%) is a potentially more sensitive parameter for assessing peripheral airway function. This post hoc analysis compared FEF25–75% with FEV1 as an endpoint to assess bronchodilator responsiveness in children with asthma. Methods Change from baseline in trough FEF25–75% and trough FEV1 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 FEF25–75% and FEV1 were calculated and analyzed. Results A total of 1590 patients were included in the analysis. Tiotropium Respimat® consistently improved FEF25–75% and FEV1 versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant. Improvements in FEF25–75% response with tiotropium versus placebo were largely more pronounced than improvements in FEV1. Statistical assessment of the correlation of FEV1 and FEF25–75% showed moderate-to-high correlations (Pearson’s correlation coefficients 0.73–0.80). Conclusions In pediatric patients, FEF25–75% may be a more sensitive measure to detect treatment response, certainly to tiotropium, than FEV1 and should be evaluated as an additional lung function measurement. |
| first_indexed | 2024-12-17T01:36:48Z |
| format | Article |
| id | doaj.art-c1669d47183840dca03f463fcc3eb098 |
| institution | Directory Open Access Journal |
| issn | 2364-1754 2364-1746 |
| language | English |
| last_indexed | 2024-12-17T01:36:48Z |
| publishDate | 2020-05-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Pulmonary Therapy |
| spelling | doaj.art-c1669d47183840dca03f463fcc3eb0982022-12-21T22:08:26ZengAdis, Springer HealthcarePulmonary Therapy2364-17542364-17462020-05-016215115810.1007/s41030-020-00117-6Forced Expiratory Flow (FEF25–75%) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc AnalysisStanley J. Szefler0Stanley Goldstein1Christian Vogelberg2George W. Bensch3John Given4Branko Jugovic5Michael Engel6Petra M. Moroni-Zentgraf7Ralf Sigmund8Eckard H. Hamelmann9Department of Pediatrics, The Breathing Institute, Children’s Hospital of Colorado, University of Colorado School of MedicineAllergy and Asthma Care of Long IslandUniversity Hospital Carl Gustav Carus, Technical University of DresdenAllergy, Immunology and Asthma Medical Group, Inc.Allergy and Respiratory CenterTA Respiratory Diseases/Biosimilars Medicine, Boehringer Ingelheim International GmbHTA Respiratory Diseases/Biosimilars Medicine, Boehringer Ingelheim International GmbHBoehringer Ingelheim Pty LtdGlobal Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG.Klinik für Kinder- Und Jugendmedizin, Kinderzentrum Bethel, Evangelisches Klinikum Bethel EvKBAbstract Introduction In pediatric patients with asthma, measurements of forced expiratory volume in 1 s (FEV1) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25–75% of the vital capacity (FEF25–75%) is a potentially more sensitive parameter for assessing peripheral airway function. This post hoc analysis compared FEF25–75% with FEV1 as an endpoint to assess bronchodilator responsiveness in children with asthma. Methods Change from baseline in trough FEF25–75% and trough FEV1 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 FEF25–75% and FEV1 were calculated and analyzed. Results A total of 1590 patients were included in the analysis. Tiotropium Respimat® consistently improved FEF25–75% and FEV1 versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant. Improvements in FEF25–75% response with tiotropium versus placebo were largely more pronounced than improvements in FEV1. Statistical assessment of the correlation of FEV1 and FEF25–75% showed moderate-to-high correlations (Pearson’s correlation coefficients 0.73–0.80). Conclusions In pediatric patients, FEF25–75% may be a more sensitive measure to detect treatment response, certainly to tiotropium, than FEV1 and should be evaluated as an additional lung function measurement.https://doi.org/10.1007/s41030-020-00117-6Airway obstructionAsthmaMuscarinic antagonistTiotropium |
| spellingShingle | Stanley J. Szefler Stanley Goldstein Christian Vogelberg George W. Bensch John Given Branko Jugovic Michael Engel Petra M. Moroni-Zentgraf Ralf Sigmund Eckard H. Hamelmann Forced Expiratory Flow (FEF25–75%) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis Pulmonary Therapy Airway obstruction Asthma Muscarinic antagonist Tiotropium |
| title | Forced Expiratory Flow (FEF25–75%) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
| title_full | Forced Expiratory Flow (FEF25–75%) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
| title_fullStr | Forced Expiratory Flow (FEF25–75%) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
| title_full_unstemmed | Forced Expiratory Flow (FEF25–75%) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
| title_short | Forced Expiratory Flow (FEF25–75%) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis |
| title_sort | forced expiratory flow fef25 75 as a clinical endpoint in children and adolescents with symptomatic asthma receiving tiotropium a post hoc analysis |
| topic | Airway obstruction Asthma Muscarinic antagonist Tiotropium |
| url | https://doi.org/10.1007/s41030-020-00117-6 |
| work_keys_str_mv | AT stanleyjszefler forcedexpiratoryflowfef2575asaclinicalendpointinchildrenandadolescentswithsymptomaticasthmareceivingtiotropiumaposthocanalysis AT stanleygoldstein forcedexpiratoryflowfef2575asaclinicalendpointinchildrenandadolescentswithsymptomaticasthmareceivingtiotropiumaposthocanalysis AT christianvogelberg forcedexpiratoryflowfef2575asaclinicalendpointinchildrenandadolescentswithsymptomaticasthmareceivingtiotropiumaposthocanalysis AT georgewbensch forcedexpiratoryflowfef2575asaclinicalendpointinchildrenandadolescentswithsymptomaticasthmareceivingtiotropiumaposthocanalysis AT johngiven forcedexpiratoryflowfef2575asaclinicalendpointinchildrenandadolescentswithsymptomaticasthmareceivingtiotropiumaposthocanalysis AT brankojugovic forcedexpiratoryflowfef2575asaclinicalendpointinchildrenandadolescentswithsymptomaticasthmareceivingtiotropiumaposthocanalysis AT michaelengel forcedexpiratoryflowfef2575asaclinicalendpointinchildrenandadolescentswithsymptomaticasthmareceivingtiotropiumaposthocanalysis AT petrammoronizentgraf forcedexpiratoryflowfef2575asaclinicalendpointinchildrenandadolescentswithsymptomaticasthmareceivingtiotropiumaposthocanalysis AT ralfsigmund forcedexpiratoryflowfef2575asaclinicalendpointinchildrenandadolescentswithsymptomaticasthmareceivingtiotropiumaposthocanalysis AT eckardhhamelmann forcedexpiratoryflowfef2575asaclinicalendpointinchildrenandadolescentswithsymptomaticasthmareceivingtiotropiumaposthocanalysis |