TY - JOUR
T1 - Bronchial Thermoplasty Global Registry (BTGR)
T2 - 2-year results
AU - Torrego, Alfons
AU - Herth, Felix J.
AU - Munoz-Fernandez, Ana M.
AU - Puente, Luis
AU - Facciolongo, Nicola
AU - Bicknell, Stephen
AU - Novali, Mauro
AU - Gasparini, Stefano
AU - Bonifazi, Martina
AU - Dheda, Keertan
AU - Andreo, Felipe
AU - Votruba, Praha
AU - Langton, David
AU - Flandes, Javier
AU - Fielding, David
AU - Bonta, Peter I.
AU - Skowasch, Dirk
AU - Schulz, Christian
AU - Darwiche, Kaid
AU - McMullen, Edmund
AU - Grubb, G. Mark
AU - Niven, Robert
N1 - Funding Information: Competing interests FH received personal fees for ad board activities and lecture fees from Pulmonx, BTG, Olympus, and Uptake. AMF reports the receipt of grants from Boston Scientific during the conduct of this study. LP reports personal fees and others from AstraZeneca, grants and other fees from GlaxoSmithKline, grants and personal fees from Esteve, personal fees and other fees from Boehringer, other fees from Teva, personal fees and other fees from Novartis, other fees from Chiesi, grants from Menarini, personal fees from MSD and Boston Scientific outside the submitted work. MN reports other fees from Boston Scientific. MB reports personal fees from Roche and Boehringer-Ingelheim outside the submitted work. DF reports other fees from Boston Scientific during the conduct of the study. PIB reports grants, non-financial support, and other fees from Boston Scientific during the conduct of the study. KD reports grants from Boston Scientific outside the submitted work. GMG is a full-time employee of Boston Scientific, the sponsor of this study. RN reports grants and personal fees from Boston Scientific outside the submitted work. Funding Information: Funding This study was sponsored by Boston Scientific Corporation, Marlborough, MA, USA. Publisher Copyright: ©
PY - 2021/12/1
Y1 - 2021/12/1
N2 - Objectives Bronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected real-world data on subjects undergoing this procedure. Design The BTGR is an all-comer, prospective, open-label, multicentre study enrolling adult subjects indicated for and treated with BT. Setting Eighteen centres in Spain, Italy, Germany, the UK, the Netherlands, the Czech Republic, South Africa and Australia Participants One hundred fifty-seven subjects aged 18 years and older who were scheduled to undergo BT treatment for asthma. Subjects diagnosed with other medical conditions which, in the investigator's opinion, made them inappropriate for BT treatment were excluded. Primary and secondary outcome measures Baseline characteristics collected included demographics, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Test (ACT), medication usage, forced expiratory volume in one second and forced vital capacity, medical history, comorbidities and 12-month baseline recall data (severe exacerbations (SE) and healthcare utilisation). SE incidence and healthcare utilisation were summarised at 1 and 2 years post-BT. Results Subjects' baseline characteristics were representative of persons with severe asthma. A comparison of the proportion of subjects experiencing events during the 12 months prior to BT to the 2-year follow-up showed a reduction in SE (90.3% vs 56.1%, p<0.0001), emergency room visits (53.8% vs 25.5%, p<0.0001) and hospitalisations (42.9% vs 23.5 %, p=0.0019). Reductions in asthma maintenance medication dosage were also observed. AQLQ and ACT scores improved from 3.26 and 11.18 at baseline to 4.39 and 15.54 at 2 years, respectively (p<0.0001 for both AQLQ and ACT). Conclusions The BTGR demonstrates sustained improvement in clinical outcomes and reduction in asthma medication usage 2 years after BT in a real-world population. This is consistent with results from other BT randomised controlled trials and registries and further supports improvement in asthma control after BT. Trial registration number NCT02104856.
AB - Objectives Bronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected real-world data on subjects undergoing this procedure. Design The BTGR is an all-comer, prospective, open-label, multicentre study enrolling adult subjects indicated for and treated with BT. Setting Eighteen centres in Spain, Italy, Germany, the UK, the Netherlands, the Czech Republic, South Africa and Australia Participants One hundred fifty-seven subjects aged 18 years and older who were scheduled to undergo BT treatment for asthma. Subjects diagnosed with other medical conditions which, in the investigator's opinion, made them inappropriate for BT treatment were excluded. Primary and secondary outcome measures Baseline characteristics collected included demographics, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Test (ACT), medication usage, forced expiratory volume in one second and forced vital capacity, medical history, comorbidities and 12-month baseline recall data (severe exacerbations (SE) and healthcare utilisation). SE incidence and healthcare utilisation were summarised at 1 and 2 years post-BT. Results Subjects' baseline characteristics were representative of persons with severe asthma. A comparison of the proportion of subjects experiencing events during the 12 months prior to BT to the 2-year follow-up showed a reduction in SE (90.3% vs 56.1%, p<0.0001), emergency room visits (53.8% vs 25.5%, p<0.0001) and hospitalisations (42.9% vs 23.5 %, p=0.0019). Reductions in asthma maintenance medication dosage were also observed. AQLQ and ACT scores improved from 3.26 and 11.18 at baseline to 4.39 and 15.54 at 2 years, respectively (p<0.0001 for both AQLQ and ACT). Conclusions The BTGR demonstrates sustained improvement in clinical outcomes and reduction in asthma medication usage 2 years after BT in a real-world population. This is consistent with results from other BT randomised controlled trials and registries and further supports improvement in asthma control after BT. Trial registration number NCT02104856.
KW - asthma
KW - bronchoscopy
KW - chronic airways disease
KW - respiratory medicine (see thoracic medicine)
UR - http://www.scopus.com/inward/record.url?scp=85122540164&partnerID=8YFLogxK
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85122540164&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/34916324
U2 - https://doi.org/10.1136/bmjopen-2021-053854
DO - https://doi.org/10.1136/bmjopen-2021-053854
M3 - Article
C2 - 34916324
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e053854
ER -