TY - JOUR
T1 - Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years
T2 - The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study
AU - Chupp, Geoffrey
AU - Kline, Joel N.
AU - Khatri, Sumita B.
AU - McEvoy, Charlene
AU - Silvestri, Gerard A.
AU - Shifren, Adrian
AU - Castro, Mario
AU - Bansal, Sundeep
AU - McClelland, Marc
AU - Dransfield, Mark
AU - Trevor, Jennifer
AU - Kahlstrom, Nick
AU - Simoff, Michael
AU - Wahidi, Momen M.
AU - Lamb, Carla R.
AU - Ferguson, J. Scott
AU - Haas, Andrew
AU - Hogarth, D. Kyle
AU - Tejedor, Richard
AU - Toth, Jennifer
AU - Hey, Jamie
AU - Majid, Adnan
AU - LaCamera, Peter
AU - Fitzgerald, J. Mark
AU - Enfield, Kyle
AU - Grubb, G. Mark
AU - McMullen, Edmund A.
AU - Olson, Jennifer L.
AU - Laviolette, Michel
N1 - Funding Information:
Financial/nonfinancial disclosures: G. C. was a member of the Boston Scientific Corp speaker’s bureau during the conduct of the study; was an asthma clinical trial investigator, was an advisory board consultant, and was on the speakers’ bureau member for GlaxoSmithKline, AstraZeneca, Genentech, Sanofi-Genzyme, Regeneron, Amgen, and Boehringer Ingelheim; and was an asthma advisory board member for Teva Pharmaceuticals. J. N. K. and S. B. K. report grants from Boston Scientific Corp during the conduct of this study. C. M. reports grants from Boston Scientific Corp and AstraZeneca during the conduct of the study, and grants from the National Institutes of Health (US), the Department of Defense (US), GlaxoSmithKline, PCORI, and the COPD Foundation, and personal fees from Respirtech (A Phillips Co), all outside the submitted work. A. S. reports grants from Boston Scientific Corp during the conduct of the study and personal fees from Genentech and Boehringer Ingelheim, both outside the submitted work. M. Castro received university grant funding from the National Institutes of Health, the American Lung Association, and PCORI, and received pharmaceutical grant funding from AstraZeneca, GlaxoSmithKline, Novartis, Pulmatrix, Sanofi-Aventis, and Shionogi; is a consultant for Genentech, Teva, Sanofi-Aventis, and Novartis; is a speaker for AstraZeneca, Genentech, GlaxoSmithKline, Regeneron, Sanofi, and Teva; and receives royalties from Elsevier. S. B. reports grants from Boston Scientific Corp, during the conduct of the study; personal fees from Boehringer Ingelheim, Auris Health - Johnson & Johnson, Veran, Sunovion Pharmaceuticals, Biodesix, Pinnacle Biologics, Circulogene Theranostics, Sanofi Genzyme and Regeneron, and GlaxoSmithKline, outside the submitted work; and personal fees and other from Veracyte, outside the submitted work. M. D. reports other support from Boston Scientific, during the conduct of the study; personal fees and other from Boehringer Ingelheim, GlaxoSmithKline, and AstraZeneca, outside the submitted work; other from Yungjin, PneumRx/BTG, Boston Scientific Corp, Gala, and Nuvaira, outside the submitted work; nonfinancial support and other from Pulmonx, outside the submitted work; personal fees from Quark Pharmaceuticals, Mereo, Teva, and CSA Medical, outside the submitted work; and grants from the American Lung Association, the NIH, the Department of Veterans Affairs, and the Department of Defense, outside the submitted work. M. S. was a consultant to Intuitive Surgical, Auris Robotics, and Gongwin Biopharm during the conduct of this study. C. R. L. reports other payments from Boston Scientific Corp, outside the submitted work. J. S. F. reports grants from Boston Scientific Corp during the conduct of the study. A. H. reports grants from Boston Scientific Corp during the conduct of the study and grants from Serpex Medical, Novocure Inc, and Olympus America Inc, all outside the submitted work. D. K. H. reports personal fees from Olympus/Spiration and PulmonX during the conduct of the study; personal fees and other from Auris, Eolo, Noah Medical, LX-Medical, Preora, Broncus, and Prothea-X, outside the submitted work; personal fees from Ambu, Johnson and Johnson, Oncocyte, Veracyte, Heritage Biologics, IDbyDNA, Level-Ex, Medtronic, Neurotronic, Olympus, PulmonX, Astra-Zeneca, Biodesix, Genetech, Grifols, Takeda, CSL, and InhibRX, outside the submitted work; personal fees, nonfinancial support, and other from Body Vision, outside the submitted work; other from Eon, Gravitas, Med-Opsys, Monogram Orthopedics, VIDA, and Viomics, outside the submitted work; and grants and personal fees from Boston Scientific Corp, and Gala, outside the submitted work. J. Toth reports other payments from Olympus Inc - Spiration Valve, outside the submitted work. A. M. reports grants from Boston Scientific Corp during the conduct of the study and other payments from Boston Scientific Corp, outside the submitted work. J. M. F. reports receiving grants from Boston Scientific Corp, which were paid directly to UBC. G. M. G., E. A. M., and J. L. O. are full-time employees of Boston Scientific Corp. M. L. reports grants and other payments from Boston Scientific Corp, GSK, AstraZeneca, and Sanofi, all outside the submitted work. None declared (G. A. S., M. McClelland, J. Trevor, N. K., M. M. W., R. T., J. H., P. L., K. E.).
Publisher Copyright:
© 2021 American College of Chest Physicians
PY - 2022/3
Y1 - 2022/3
N2 - Background: Bronchial thermoplasty is a device-based treatment for subjects ≥ 18 years of age with severe asthma poorly controlled with inhaled corticosteroids and long-acting beta-agonists. The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma (PAS2) study collected data on patients with severe asthma undergoing this procedure. Research Question: What are the 5-year efficacy and safety results in patients with severe asthma who have undergone bronchial thermoplasty? Study Design and Methods: This was a prospective, open-label, observational, multicenter study conducted in the United States and Canada. Subjects 18 to 65 years of age who were taking inhaled corticosteroids ≥ 1,000 μg/d (beclomethasone or equivalent) and long-acting beta-agonists ≥ 80 μg/d (salmeterol or equivalent) were included. Severe exacerbations, hospitalization, ED visits, and medication usage were evaluated for the 12 months prior to and at years 1 through 5 posttreatment. Spirometry was evaluated at baseline and at years 1 through 5 posttreatment. Results: A total of 284 subjects were enrolled at 27 centers; 227 subjects (80%) completed 5 years of follow-up. By year 5 posttreatment, the proportion of subjects with severe exacerbations, ED visits, and hospitalizations was 42.7%, 7.9%, and 4.8%, respectively, compared with 77.8%, 29.4%, and 16.1% in the 12 months prior to treatment. The proportion of subjects on maintenance oral corticosteroids decreased from 19.4% at baseline to 9.7% at 5 years. Analyses of subgroups based on baseline clinical and biomarker characteristics revealed a statistically significant clinical improvement among all subgroups. Interpretation: Five years after treatment, subjects experienced decreases in severe exacerbations, hospitalizations, ED visits, and corticosteroid exposure. All subgroups demonstrated clinically significant improvement, suggesting that bronchial thermoplasty improves asthma control in different asthma phenotypes. Clinical Trial Registration: ClinicalTrials.gov; No.: NCT01350336; URL: www.clinicaltrials.gov
AB - Background: Bronchial thermoplasty is a device-based treatment for subjects ≥ 18 years of age with severe asthma poorly controlled with inhaled corticosteroids and long-acting beta-agonists. The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma (PAS2) study collected data on patients with severe asthma undergoing this procedure. Research Question: What are the 5-year efficacy and safety results in patients with severe asthma who have undergone bronchial thermoplasty? Study Design and Methods: This was a prospective, open-label, observational, multicenter study conducted in the United States and Canada. Subjects 18 to 65 years of age who were taking inhaled corticosteroids ≥ 1,000 μg/d (beclomethasone or equivalent) and long-acting beta-agonists ≥ 80 μg/d (salmeterol or equivalent) were included. Severe exacerbations, hospitalization, ED visits, and medication usage were evaluated for the 12 months prior to and at years 1 through 5 posttreatment. Spirometry was evaluated at baseline and at years 1 through 5 posttreatment. Results: A total of 284 subjects were enrolled at 27 centers; 227 subjects (80%) completed 5 years of follow-up. By year 5 posttreatment, the proportion of subjects with severe exacerbations, ED visits, and hospitalizations was 42.7%, 7.9%, and 4.8%, respectively, compared with 77.8%, 29.4%, and 16.1% in the 12 months prior to treatment. The proportion of subjects on maintenance oral corticosteroids decreased from 19.4% at baseline to 9.7% at 5 years. Analyses of subgroups based on baseline clinical and biomarker characteristics revealed a statistically significant clinical improvement among all subgroups. Interpretation: Five years after treatment, subjects experienced decreases in severe exacerbations, hospitalizations, ED visits, and corticosteroid exposure. All subgroups demonstrated clinically significant improvement, suggesting that bronchial thermoplasty improves asthma control in different asthma phenotypes. Clinical Trial Registration: ClinicalTrials.gov; No.: NCT01350336; URL: www.clinicaltrials.gov
KW - asthma subgroups
KW - bronchial thermoplasty
KW - corticosteroid exposure
KW - severe asthma
KW - severe exacerbations
UR - http://www.scopus.com/inward/record.url?scp=85124408405&partnerID=8YFLogxK
U2 - 10.1016/j.chest.2021.10.044
DO - 10.1016/j.chest.2021.10.044
M3 - Article
C2 - 34774528
AN - SCOPUS:85124408405
VL - 161
SP - 614
EP - 628
JO - Chest
JF - Chest
SN - 0012-3692
IS - 3
ER -