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:
FUNDING/SUPPORT: This study was sponsored by Boston Scientific Corp , Marlborough, MA.
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
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U2 - 10.1016/j.chest.2021.10.044
DO - 10.1016/j.chest.2021.10.044
M3 - Article
C2 - 34774528
AN - SCOPUS:85124408405
SN - 0012-3692
VL - 161
SP - 614
EP - 628
JO - CHEST
JF - CHEST
IS - 3
ER -