Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma
Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. BT-treated subjects from the Asthma Intervention Research 2 tr...
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| Published in | Journal of allergy and clinical immunology Vol. 132; no. 6; pp. 1295 - 1302.e3 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York, NY
Mosby, Inc
01.12.2013
Elsevier Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0091-6749 1097-6825 1097-6825 |
| DOI | 10.1016/j.jaci.2013.08.009 |
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| Abstract | Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.
We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.
BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans.
One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV1 values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT.
These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β2-agonists. |
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| AbstractList | Background Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. Objective We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. Methods BT-treated subjects from the Asthma Intervention Research 2 trial ( ClinicalTrials.gov NCT01350414 ) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. Results One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV1 values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. Conclusions These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β2 -agonists. Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists. Background: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.BACKGROUNDBronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.OBJECTIVEWe sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans.METHODSBT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans.One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT.RESULTSOne hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT.These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists.CONCLUSIONSThese data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists. Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV1 values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β2-agonists. BACKGROUND: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. OBJECTIVE: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. METHODS: BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. RESULTS: One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. CONCLUSIONS: These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists. Background Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. Objective We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. Methods BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. Results One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV1values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. Conclusions These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β2-agonists. |
| Author | Sterman, Daniel H. Pavord, Ian D. Armstrong, Brian Slebos, Dirk-Jan Shargill, Narinder S. Castro, Mario Thomson, Neil C. Leeds, William M. Holmes, Mark Kraft, Monica Phillips, Martin J. Mansur, Adel H. Wechsler, Michael E. Hanania, Nicola A. Cox, Gerard Niven, Robert M. Shah, Pallav L. Hales, Jeff B. Austin, John H.M. Rubin, Adalberto S. Kline, Joel N. Lapa e Silva, Jose R. McEvoy, Charlene Quiring, John Olivenstein, Ronald Fiss, Elie Laviolette, Michel Erzurum, Serpil C. Sumino, Kaharu Barbers, Richard G. Fiterman, Jussara Louie, Brian E. Simoff, Michael Hogarth, Kyle |
| Author_xml | – sequence: 1 givenname: Michael E. surname: Wechsler fullname: Wechsler, Michael E. email: mikewechsler@gmail.com organization: Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colo – sequence: 2 givenname: Michel surname: Laviolette fullname: Laviolette, Michel organization: Département de Pneumologie, IUCPQ (Hôpital Laval), Laval University, Laval, Quebec, Canada – sequence: 3 givenname: Adalberto S. surname: Rubin fullname: Rubin, Adalberto S. organization: Servico de Pneumologia, Irmandade Santa Casa de Misericórdia da Porto Alegre, Porto Alegre, Brazil – sequence: 4 givenname: Jussara surname: Fiterman fullname: Fiterman, Jussara organization: Hospital São Lucas da PUCRS, Porto Alegre, Brazil – sequence: 5 givenname: Jose R. surname: Lapa e Silva fullname: Lapa e Silva, Jose R. organization: Hospital Universitário Clementino Fraga Filho, Rio de Janeiro, Brazil – sequence: 6 givenname: Pallav L. surname: Shah fullname: Shah, Pallav L. organization: Respiratory, General & Intensive Care Medicine, Chelsea & Westminster Hospital NHS Foundation Trust, London, United Kingdom – sequence: 7 givenname: Elie surname: Fiss fullname: Fiss, Elie organization: Faculdade de Medicina do ABC, Santo André, São Paulo, Brazil – sequence: 8 givenname: Ronald surname: Olivenstein fullname: Olivenstein, Ronald organization: Montreal Chest Institute, Montreal, Quebec, Canada – sequence: 9 givenname: Neil C. surname: Thomson fullname: Thomson, Neil C. organization: Department of Respiratory Medicine, Gartnavel General Hospital, University of Glasgow, Glasgow, United Kingdom – sequence: 10 givenname: Robert M. surname: Niven fullname: Niven, Robert M. organization: MAHSC, University of Manchester and University Hospital of South Manchester, Manchester, United Kingdom – sequence: 11 givenname: Ian D. surname: Pavord fullname: Pavord, Ian D. organization: Division of Respiratory Medicine, Glenfield General Hospital, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom – sequence: 12 givenname: Michael surname: Simoff fullname: Simoff, Michael organization: Division of Pulmonary and Critical Care Medicine, Henry Ford Medical Center, Detroit, Mich – sequence: 13 givenname: Jeff B. surname: Hales fullname: Hales, Jeff B. organization: Pulmonary and Medical Associate of Northern Virginia, Arlington, Va – sequence: 14 givenname: Charlene surname: McEvoy fullname: McEvoy, Charlene organization: HealthPartners Specialty Center- Lung and Sleep Health, St Paul, Minn – sequence: 15 givenname: Dirk-Jan surname: Slebos fullname: Slebos, Dirk-Jan organization: Department of Pulmonary Diseases, Universtair Medisch Centrum, Groningen, The Netherlands – sequence: 16 givenname: Mark surname: Holmes fullname: Holmes, Mark organization: Respiratory Clinical Trials Unit, Royal Adelaide Hospital, Adelaide, Australia – sequence: 17 givenname: Martin J. surname: Phillips fullname: Phillips, Martin J. organization: Western Australia Lung Research, Sir Charles Gairdner Hospital, Perth, Australia – sequence: 18 givenname: Serpil C. surname: Erzurum fullname: Erzurum, Serpil C. organization: Department of Pulmonary and Critical Care Medicine, Cleveland Clinic, Cleveland, Ohio – sequence: 19 givenname: Nicola A. surname: Hanania fullname: Hanania, Nicola A. organization: Section of Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston, Tex – sequence: 20 givenname: Kaharu surname: Sumino fullname: Sumino, Kaharu organization: Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St Louis, Mo – sequence: 21 givenname: Monica surname: Kraft fullname: Kraft, Monica organization: Department of Pulmonary Medicine, Duke University Medical Center, Durham, NC – sequence: 22 givenname: Gerard surname: Cox fullname: Cox, Gerard organization: St Joseph's Healthcare, Firestone Institute of Respiratory Health, McMaster University, Hamilton, Ontario, Canada – sequence: 23 givenname: Daniel H. surname: Sterman fullname: Sterman, Daniel H. organization: Section of Interventional Pulmonology and Thoracic Oncology, Pulmonary, Allergy, and Critical Care Division, the University of Pennsylvania Health System, Philadelphia, Pa – sequence: 24 givenname: Kyle surname: Hogarth fullname: Hogarth, Kyle organization: Department of Pulmonary and Critical Care Medicine, University of Chicago, Chicago, Ill – sequence: 25 givenname: Joel N. surname: Kline fullname: Kline, Joel N. organization: Pulmonary, Critical Care and Occupational Medicine, University of Iowa, Iowa City, Iowa – sequence: 26 givenname: Adel H. surname: Mansur fullname: Mansur, Adel H. organization: Birmingham Heartlands Hospital, Respiratory Unit, University of Birmingham, Birmingham, United Kingdom – sequence: 27 givenname: Brian E. surname: Louie fullname: Louie, Brian E. organization: Section of Thoracic and Foregut Surgery, Swedish Medical Center, Seattle, Wash – sequence: 28 givenname: William M. surname: Leeds fullname: Leeds, William M. organization: Veritas Clinical Specialties, Topeka, Kan – sequence: 29 givenname: Richard G. surname: Barbers fullname: Barbers, Richard G. organization: Division of Pulmonary and Critical Care Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, Calif – sequence: 30 givenname: John H.M. surname: Austin fullname: Austin, John H.M. organization: Division of Radiology, Columbia University Medical Center, New York, NY – sequence: 31 givenname: Narinder S. surname: Shargill fullname: Shargill, Narinder S. organization: Boston Scientific Corp, Sunnyvale, Calif – sequence: 32 givenname: John surname: Quiring fullname: Quiring, John organization: QST Consultations Ltd, Allendale, Mich – sequence: 33 givenname: Brian surname: Armstrong fullname: Armstrong, Brian organization: QST Consultations Ltd, Allendale, Mich – sequence: 34 givenname: Mario surname: Castro fullname: Castro, Mario organization: Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St Louis, Mo |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28023751$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/23998657$$D View this record in MEDLINE/PubMed |
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| Snippet | Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.
We sought to assess... Background Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. Objective... Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.BACKGROUNDBronchial... Background: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. BACKGROUND: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.... |
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| SubjectTerms | adrenal cortex hormones Adrenal Cortex Hormones - therapeutic use Adrenergic beta-Agonists - therapeutic use Adult Alair System Allergy and Immunology Asthma Asthma - epidemiology Asthma - therapy asthma exacerbation beta-adrenergic agonists Biological and medical sciences Bronchial thermoplasty bronchoscopic procedure computed tomography Disease Progression Drug Resistance durability Electric Stimulation Therapy - methods Emergency Medical Services - statistics & numerical data Female Follow-Up Studies Fundamental and applied biological sciences. Psychology Fundamental immunology health services Hospitalization Hospitalization - statistics & numerical data Humans Male Medical sciences Medical treatment Middle Aged patients Recurrence Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis therapeutics Time Factors Treatment Outcome Young Adult |
| Title | Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma |
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