Annika W M Goorsenberg1, Julia N S d'Hooghe2, Karthikan Srikanthan3, Nick H T Ten Hacken4, Els J M Weersink5, Joris J T H Roelofs6, Samuel V Kemp7,8, Elisabeth H Bel5, Pallav L Shah7,8,9, Jouke T Annema1, Peter I Bonta10. 1. Amsterdam UMC, 522567, University of Amsterdam, Department of Respiratory Medicine, Amsterdam, The Netherlands., Amsterdam, Netherlands. 2. University of Amsterdam, 1234, Department of Respiratory Medicine, Amsterdam, The Netherlands., Amsterdam, Netherlands. 3. Royal Brompton and Harefield NHS Foundation Trust, 4964, Respiratory Medicine, London, United Kingdom of Great Britain and Northern Ireland. 4. University Medical Center Groningen, Groningen, Netherlands. 5. Amsterdam University Medical Centres, 522567, Respiratory Medicine, Amsterdam, Netherlands. 6. Amsterdam University Medical Centres, 522567, Pathology, Amsterdam, Netherlands. 7. Royal Brompton and Harefield NHS Foundation Trust, 4964, London, United Kingdom of Great Britain and Northern Ireland. 8. National Heart and Lung Institute, 90897, London, United Kingdom of Great Britain and Northern Ireland. 9. Chelsea and Westminster Hospital, 112004, Pulmonology, London, United Kingdom of Great Britain and Northern Ireland. 10. Amsterdam UMC, 522567, University of Amsterdam, Department of Respiratory Medicine, Amsterdam, The Netherlands., Amsterdam, Netherlands; p.i.bonta@amsterdamumc.nl.
Abstract
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. AIMS: First, to assess the effect of BT on ASM mass and second, to identify patient characteristics that correlate with BT-response. METHODS:Severe asthma patients (n=40) were randomized to immediate (n=20) or delayed (n=20) BT-treatment. Prior to randomization, clinical, functional, blood and airway biopsy data were collected. In the delayed control group, re-assessment, 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 α-smooth muscle actin area in the total biopsy) was calculated with automated digital analyses software. Associations between baseline characteristics and Asthma Control and Asthma Quality of Life Questionnaire (ACQ/AQLQ) improvement were explored. 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 ACQ scores improved with -0.79 (-1.61;0.02 IQR) compared to 0.09 (-0.25;1.17 IQR) in the delayed group (p=0.006). AQLQ scores improved with 0.83 (-0.15;1.69 IQR) versus -0.02 (-0.77;0.75 IQR) (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. CONCLUSION: ASM mass significantly decreases after BT when compared to a randomized non-BT treated control group. Treatment response was associated with serum IgE and eosinophil levels but not with ASM mass. Clinical trial registration available at www.clinicaltrials.gov, ID:NCT0222539.
RCT Entities:
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. AIMS: First, to assess the effect of BT on ASM mass and second, to identify patient characteristics that correlate with BT-response. METHODS: Severe asthmapatients (n=40) were randomized to immediate (n=20) or delayed (n=20) BT-treatment. Prior to randomization, clinical, functional, blood and airway biopsy data were collected. In the delayed control group, re-assessment, 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 α-smooth muscle actin area in the total biopsy) was calculated with automated digital analyses software. Associations between baseline characteristics and Asthma Control and Asthma Quality of Life Questionnaire (ACQ/AQLQ) improvement were explored. 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 ACQ scores improved with -0.79 (-1.61;0.02 IQR) compared to 0.09 (-0.25;1.17 IQR) in the delayed group (p=0.006). AQLQ scores improved with 0.83 (-0.15;1.69 IQR) versus -0.02 (-0.77;0.75 IQR) (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. CONCLUSION:ASM mass significantly decreases after BT when compared to a randomized non-BT treated control group. Treatment response was associated with serum IgE and eosinophil levels but not with ASM mass. Clinical trial registration available at www.clinicaltrials.gov, ID:NCT0222539.
Entities:
Keywords:
airway remodeling; airway smooth muscle; bronchial thermoplasty; severe asthma
Authors: Christina Bal; Casper Falster; Andre Carvalho; Nicole Hersch; Judith Brock; Christian B Laursen; Simon Walsh; Jouke Annema; Daniela Gompelmann Journal: ERJ Open Res Date: 2022-05-23
Authors: Margherita Vaselli; Pieta C Wijsman; Joy Willemse; Annika W M Goorsenberg; Fabio Feroldi; Julia N S d'Hooghe; Jouke T Annema; Johannes F de Boer; Peter I Bonta Journal: Chest Date: 2021-03-27 Impact factor: 9.410