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Bronchial Thermoplasty Global Registry (BTGR): 2-year results
OBJECTIVES: Bronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected real-world data on subjects undergoing this proced...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8679080/ https://www.ncbi.nlm.nih.gov/pubmed/34916324 http://dx.doi.org/10.1136/bmjopen-2021-053854 |
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author | Torrego, Alfons Herth, Felix J Munoz-Fernandez, Ana M Puente, Luis Facciolongo, Nicola Bicknell, Stephen Novali, Mauro Gasparini, Stefano Bonifazi, Martina Dheda, Keertan Andreo, Felipe Votruba, Praha Langton, David Flandes, Javier Fielding, David Bonta, Peter I Skowasch, Dirk Schulz, Christian Darwiche, Kaid McMullen, Edmund Grubb, G. Mark Niven, Robert |
author_facet | Torrego, Alfons Herth, Felix J Munoz-Fernandez, Ana M Puente, Luis Facciolongo, Nicola Bicknell, Stephen Novali, Mauro Gasparini, Stefano Bonifazi, Martina Dheda, Keertan Andreo, Felipe Votruba, Praha Langton, David Flandes, Javier Fielding, David Bonta, Peter I Skowasch, Dirk Schulz, Christian Darwiche, Kaid McMullen, Edmund Grubb, G. Mark Niven, Robert |
author_sort | Torrego, Alfons |
collection | PubMed |
description | OBJECTIVES: Bronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected real-world data on subjects undergoing this procedure. DESIGN: The BTGR is an all-comer, prospective, open-label, multicentre study enrolling adult subjects indicated for and treated with BT. SETTING: Eighteen centres in Spain, Italy, Germany, the UK, the Netherlands, the Czech Republic, South Africa and Australia PARTICIPANTS: One hundred fifty-seven subjects aged 18 years and older who were scheduled to undergo BT treatment for asthma. Subjects diagnosed with other medical conditions which, in the investigator’s opinion, made them inappropriate for BT treatment were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES: Baseline characteristics collected included demographics, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Test (ACT), medication usage, forced expiratory volume in one second and forced vital capacity, medical history, comorbidities and 12-month baseline recall data (severe exacerbations (SE) and healthcare utilisation). SE incidence and healthcare utilisation were summarised at 1 and 2 years post-BT. RESULTS: Subjects’ baseline characteristics were representative of persons with severe asthma. A comparison of the proportion of subjects experiencing events during the 12 months prior to BT to the 2-year follow-up showed a reduction in SE (90.3% vs 56.1%, p<0.0001), emergency room visits (53.8% vs 25.5%, p<0.0001) and hospitalisations (42.9% vs 23.5 %, p=0.0019). Reductions in asthma maintenance medication dosage were also observed. AQLQ and ACT scores improved from 3.26 and 11.18 at baseline to 4.39 and 15.54 at 2 years, respectively (p<0.0001 for both AQLQ and ACT). CONCLUSIONS: The BTGR demonstrates sustained improvement in clinical outcomes and reduction in asthma medication usage 2 years after BT in a real-world population. This is consistent with results from other BT randomised controlled trials and registries and further supports improvement in asthma control after BT. TRIAL REGISTRATION NUMBER: NCT02104856. |
format | Online Article Text |
id | pubmed-8679080 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-86790802022-01-04 Bronchial Thermoplasty Global Registry (BTGR): 2-year results Torrego, Alfons Herth, Felix J Munoz-Fernandez, Ana M Puente, Luis Facciolongo, Nicola Bicknell, Stephen Novali, Mauro Gasparini, Stefano Bonifazi, Martina Dheda, Keertan Andreo, Felipe Votruba, Praha Langton, David Flandes, Javier Fielding, David Bonta, Peter I Skowasch, Dirk Schulz, Christian Darwiche, Kaid McMullen, Edmund Grubb, G. Mark Niven, Robert BMJ Open Respiratory Medicine OBJECTIVES: Bronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected real-world data on subjects undergoing this procedure. DESIGN: The BTGR is an all-comer, prospective, open-label, multicentre study enrolling adult subjects indicated for and treated with BT. SETTING: Eighteen centres in Spain, Italy, Germany, the UK, the Netherlands, the Czech Republic, South Africa and Australia PARTICIPANTS: One hundred fifty-seven subjects aged 18 years and older who were scheduled to undergo BT treatment for asthma. Subjects diagnosed with other medical conditions which, in the investigator’s opinion, made them inappropriate for BT treatment were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES: Baseline characteristics collected included demographics, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Test (ACT), medication usage, forced expiratory volume in one second and forced vital capacity, medical history, comorbidities and 12-month baseline recall data (severe exacerbations (SE) and healthcare utilisation). SE incidence and healthcare utilisation were summarised at 1 and 2 years post-BT. RESULTS: Subjects’ baseline characteristics were representative of persons with severe asthma. A comparison of the proportion of subjects experiencing events during the 12 months prior to BT to the 2-year follow-up showed a reduction in SE (90.3% vs 56.1%, p<0.0001), emergency room visits (53.8% vs 25.5%, p<0.0001) and hospitalisations (42.9% vs 23.5 %, p=0.0019). Reductions in asthma maintenance medication dosage were also observed. AQLQ and ACT scores improved from 3.26 and 11.18 at baseline to 4.39 and 15.54 at 2 years, respectively (p<0.0001 for both AQLQ and ACT). CONCLUSIONS: The BTGR demonstrates sustained improvement in clinical outcomes and reduction in asthma medication usage 2 years after BT in a real-world population. This is consistent with results from other BT randomised controlled trials and registries and further supports improvement in asthma control after BT. TRIAL REGISTRATION NUMBER: NCT02104856. BMJ Publishing Group 2021-12-16 /pmc/articles/PMC8679080/ /pubmed/34916324 http://dx.doi.org/10.1136/bmjopen-2021-053854 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Respiratory Medicine Torrego, Alfons Herth, Felix J Munoz-Fernandez, Ana M Puente, Luis Facciolongo, Nicola Bicknell, Stephen Novali, Mauro Gasparini, Stefano Bonifazi, Martina Dheda, Keertan Andreo, Felipe Votruba, Praha Langton, David Flandes, Javier Fielding, David Bonta, Peter I Skowasch, Dirk Schulz, Christian Darwiche, Kaid McMullen, Edmund Grubb, G. Mark Niven, Robert Bronchial Thermoplasty Global Registry (BTGR): 2-year results |
title | Bronchial Thermoplasty Global Registry (BTGR): 2-year results |
title_full | Bronchial Thermoplasty Global Registry (BTGR): 2-year results |
title_fullStr | Bronchial Thermoplasty Global Registry (BTGR): 2-year results |
title_full_unstemmed | Bronchial Thermoplasty Global Registry (BTGR): 2-year results |
title_short | Bronchial Thermoplasty Global Registry (BTGR): 2-year results |
title_sort | bronchial thermoplasty global registry (btgr): 2-year results |
topic | Respiratory Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8679080/ https://www.ncbi.nlm.nih.gov/pubmed/34916324 http://dx.doi.org/10.1136/bmjopen-2021-053854 |
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