Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial.
BACKGROUND: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. METHODS: Patients enrolled in the Asthma Intervention Research...
Main Authors: | , , , , , , , , , , |
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Format: | Journal article |
Language: | English |
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BioMed Central
2011
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author | Thomson, N Rubin, A Niven, R Corris, P Siersted, H Olivenstein, R Pavord, I McCormack, D Laviolette, M Shargill, N Cox, G |
author_facet | Thomson, N Rubin, A Niven, R Corris, P Siersted, H Olivenstein, R Pavord, I McCormack, D Laviolette, M Shargill, N Cox, G |
author_sort | Thomson, N |
collection | OXFORD |
description | BACKGROUND: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. METHODS: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial evaluation at 1 year, subjects were invited to participate in a 4 year safety study. Adverse events (AEs) and spirometry data were used to assess long-term safety out to 5 years post-BT. RESULTS: 45 of 52 treated and 24 of 49 control group subjects participated in long-term follow-up of 5 years and 3 years respectively. The rate of respiratory adverse events (AEs/subject) was stable in years 2 to 5 following BT (1.2, 1.3, 1.2, and 1.1, respectively,). There was no increase in hospitalizations or emergency room visits for respiratory symptoms in Years 2, 3, 4, and 5 compared to Year 1. The FVC and FEV1 values showed no deterioration over the 5 year period in the BT group. Similar results were obtained for the Control group. CONCLUSIONS: The absence of clinical complications (based on AE reporting) and the maintenance of stable lung function (no deterioration of FVC and FEV1) over a 5-year period post-BT in this group of patients with moderate to severe asthma support the long-term safety of the procedure out to 5 years. |
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format | Journal article |
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institution | University of Oxford |
language | English |
last_indexed | 2024-03-07T01:05:33Z |
publishDate | 2011 |
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spelling | oxford-uuid:8b35de00-21fa-4928-8941-f61b65ae243e2022-03-26T22:36:39ZLong-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:8b35de00-21fa-4928-8941-f61b65ae243eEnglishSymplectic Elements at OxfordBioMed Central2011Thomson, NRubin, ANiven, RCorris, PSiersted, HOlivenstein, RPavord, IMcCormack, DLaviolette, MShargill, NCox, GBACKGROUND: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. METHODS: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial evaluation at 1 year, subjects were invited to participate in a 4 year safety study. Adverse events (AEs) and spirometry data were used to assess long-term safety out to 5 years post-BT. RESULTS: 45 of 52 treated and 24 of 49 control group subjects participated in long-term follow-up of 5 years and 3 years respectively. The rate of respiratory adverse events (AEs/subject) was stable in years 2 to 5 following BT (1.2, 1.3, 1.2, and 1.1, respectively,). There was no increase in hospitalizations or emergency room visits for respiratory symptoms in Years 2, 3, 4, and 5 compared to Year 1. The FVC and FEV1 values showed no deterioration over the 5 year period in the BT group. Similar results were obtained for the Control group. CONCLUSIONS: The absence of clinical complications (based on AE reporting) and the maintenance of stable lung function (no deterioration of FVC and FEV1) over a 5-year period post-BT in this group of patients with moderate to severe asthma support the long-term safety of the procedure out to 5 years. |
spellingShingle | Thomson, N Rubin, A Niven, R Corris, P Siersted, H Olivenstein, R Pavord, I McCormack, D Laviolette, M Shargill, N Cox, G Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. |
title | Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. |
title_full | Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. |
title_fullStr | Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. |
title_full_unstemmed | Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. |
title_short | Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. |
title_sort | long term 5 year safety of bronchial thermoplasty asthma intervention research air trial |
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