TY - JOUR
T1 - Bronchial thermoplasty induced airway smooth muscle reduction and clinical response in severe asthma the TASMA randomized trial
AU - on behalf of the TASMA Research Group
AU - Goorsenberg, Annika W.M.
AU - d’Hooghe, Julia N.S.
AU - Srikanthan, Karthikan
AU - ten Hacken, Nick H.T.
AU - Weersink, Els J.M.
AU - Roelofs, Joris J.T.H.
AU - Kemp, Samuel V.
AU - Bel, Elisabeth H.
AU - Shah, Pallav L.
AU - Annema, Jouke T.
AU - Bonta, Peter I.
N1 - Funding Information: *These authors contributed equally to this work. ‡Share last authorship. TASMA Research Group: C. Caneja, J. Hartman, S. Augustijn, M. van de Pol, S. Lone-Latif, O. de Boer, and T. Dirksen. The TASMA study is funded by the Dutch Lung Foundation (grant number 5.2.13.064JO), the Netherlands Organization for Health Research and Development (ZonMw) (grant number 90713477), and Boston Scientific. Author Contributions: A.W.M.G. and J.N.S.d’H. contributed to the acquisition, analysis, and interpretation of the data and drafting the manuscript. K.S., E.J.M.W., and S.V.K. contributed to the acquisition and interpretation of the data. J.J.T.H.R. contributed to the acquisition and analysis of the data. N.H.T.t.H., E.H.B., P.L.S., J.T.A., and P.I.B. contributed to the conception and design of the study and the acquisition and interpretation of the data. All authors critically revised and approved the final version of the manuscript. Publisher Copyright: Copyright © 2021 by the American Thoracic Society. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/1/15
Y1 - 2021/1/15
N2 - Rationale: Bronchial thermoplasty (BT) is a bronchoscopic treatment for severe asthma targeting airway smooth muscle (ASM). Observational studies have shown ASM mass reduction after BT, but appropriate control groups are lacking. Furthermore, as treatment response is variable, identifying optimal candidates for BT treatment is important. Objectives: First, to assess the effect of BT on ASM mass, and second, to identify patient characteristics that correlate with BT response. Methods: Patients with severe asthma (n = 40) were randomized to immediate (n = 20) or delayed (n = 20) BT treatment. Before randomization, clinical, functional, blood, and airway biopsy data were collected. In the delayed control group, reassessment, including biopsies, was performed after 6 months of standard clinical care, followed by BT. In both groups, post-BT data including biopsies were obtained after 6 months. ASM mass (% positive desmin or a-smooth muscle actin area in the total biopsy) was calculated with automated digital analysis software. Associations between baseline characteristics and Asthma Control Questionnaire and Asthma Quality of Life Questionnaire (AQLQ) improvement were explored. Measurements and Main Results: Median ASM mass decreased by .50% in the immediate BT group (n = 17) versus no change in the delayed control group (n = 19) (P = 0.0004). In the immediate group, Asthma Control Questionnaire scores improved with 20.79 (interquartile range [IQR], 21.61 to 0.02) compared with 0.09 (IQR, 20.25 to 1.17) in the delayed group (P = 0.006). AQLQ scores improved with 0.83 (IQR, 20.15 to 1.69) versus 20.02 (IQR, 20.77 to 0.75) (P = 0.04). Treatment response in the total group (n = 35) was positively associated with serum IgE and eosinophils but not with baseline ASM mass. Conclusions: ASM mass significantly decreases after BT when compared with a randomized non–BT-treated control group. Treatment response was associated with serum IgE and eosinophil levels but not with ASM mass.
AB - Rationale: Bronchial thermoplasty (BT) is a bronchoscopic treatment for severe asthma targeting airway smooth muscle (ASM). Observational studies have shown ASM mass reduction after BT, but appropriate control groups are lacking. Furthermore, as treatment response is variable, identifying optimal candidates for BT treatment is important. Objectives: First, to assess the effect of BT on ASM mass, and second, to identify patient characteristics that correlate with BT response. Methods: Patients with severe asthma (n = 40) were randomized to immediate (n = 20) or delayed (n = 20) BT treatment. Before randomization, clinical, functional, blood, and airway biopsy data were collected. In the delayed control group, reassessment, including biopsies, was performed after 6 months of standard clinical care, followed by BT. In both groups, post-BT data including biopsies were obtained after 6 months. ASM mass (% positive desmin or a-smooth muscle actin area in the total biopsy) was calculated with automated digital analysis software. Associations between baseline characteristics and Asthma Control Questionnaire and Asthma Quality of Life Questionnaire (AQLQ) improvement were explored. Measurements and Main Results: Median ASM mass decreased by .50% in the immediate BT group (n = 17) versus no change in the delayed control group (n = 19) (P = 0.0004). In the immediate group, Asthma Control Questionnaire scores improved with 20.79 (interquartile range [IQR], 21.61 to 0.02) compared with 0.09 (IQR, 20.25 to 1.17) in the delayed group (P = 0.006). AQLQ scores improved with 0.83 (IQR, 20.15 to 1.69) versus 20.02 (IQR, 20.77 to 0.75) (P = 0.04). Treatment response in the total group (n = 35) was positively associated with serum IgE and eosinophils but not with baseline ASM mass. Conclusions: ASM mass significantly decreases after BT when compared with a randomized non–BT-treated control group. Treatment response was associated with serum IgE and eosinophil levels but not with ASM mass.
KW - Airway remodeling
KW - Airway smooth muscle
KW - Bronchial thermoplasty
KW - Severe asthma
UR - http://www.scopus.com/inward/record.url?scp=85097445202&partnerID=8YFLogxK
U2 - https://doi.org/10.1164/rccm.201911-2298OC
DO - https://doi.org/10.1164/rccm.201911-2298OC
M3 - Article
C2 - 32721210
SN - 1073-449X
VL - 203
SP - 175
EP - 184
JO - American journal of respiratory and critical care medicine
JF - American journal of respiratory and critical care medicine
IS - 2
ER -