Journal article
Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study
Chest, Vol.161(3), pp.614-628
03/2022
DOI: 10.1016/j.chest.2021.10.044
PMID: 34774528
Abstract
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.
What are the 5-year efficacy and safety results in patients with severe asthma who have undergone bronchial thermoplasty?
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.
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.
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.
ClinicalTrials.gov; No.: NCT01350336; URL: www.
gov.
Details
- Title: Subtitle
- Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study
- Creators
- Geoffrey Chupp - Yale UniversityJoel N Kline - University of IowaSumita B Khatri - Cleveland ClinicCharlene McEvoy - HealthPartnersGerard A Silvestri - Medical University of South CarolinaAdrian Shifren - Washington University in St. LouisMario Castro - University of KansasSundeep Bansal - Penn Highlands HealthcareMarc McClelland - Spectrum HealthMark Dransfield - University of Alabama at BirminghamJennifer Trevor - University of Alabama at BirminghamNick Kahlstrom - St. Joseph Medical Center in TacomaMichael Simoff - Henry Ford HospitalMomen M Wahidi - Duke UniversityCarla R Lamb - Lahey Hospital and Medical CenterJ Scott Ferguson - University of Wisconsin–MadisonAndrew Haas - University of PennsylvaniaD Kyle Hogarth - University of ChicagoRichard Tejedor - Louisiana State University Health Sciences Center New OrleansJennifer Toth - Pennsylvania State UniversityJamie HeyAdnan Majid - Beth Israel Deaconess Medical CenterPeter LaCamera - St. Elizabeth's Medical CenterJ Mark Fitzgerald - University of British ColumbiaKyle Enfield - University of Virginia Health SystemG Mark Grubb - Boston ScientificEdmund A McMullen - Boston ScientificJennifer L Olson - Boston ScientificMichel Laviolette - Université Laval
- Resource Type
- Journal article
- Publication Details
- Chest, Vol.161(3), pp.614-628
- DOI
- 10.1016/j.chest.2021.10.044
- PMID
- 34774528
- ISSN
- 0012-3692
- eISSN
- 1931-3543
- Grant note
- DOI: 10.13039/100008497, name: Boston Scientific Corporation
- Language
- English
- Date published
- 03/2022
- Academic Unit
- Pulmonary, Critical Care, and Occupational Medicine; Occupational and Environmental Health; Internal Medicine
- Record Identifier
- 9984360158602771
Metrics
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