RATIONALE: Even in stable asthma patients, acinar ventilation distribution can be abnormal, and we aimed to specifically maximize its reversibility by switching patients from a standard inhaled corticosteroid (iCS) to a fine particle iCS formulation. METHODS: For this prospective double-blind double-dummy randomized study, 66 stable asthma patients under maintenance iCS (equivalent budesonide ≤ 800 μg/day) were screened for abnormal baseline acinar ventilation heterogeneity (Sacin). After a 3-week run-in period, 35 eligible patients were randomized to fine particle beclomethasone (HFA-BDP; Qvar Autohaler) or to budesonide (DPI-BUD; Pulmicort Turbohaler). Asthma Control Test (ACT) score and various lung function indices reflecting the small airways were obtained at baseline, after 6 and 12 weeks. RESULTS:Thirty one patients [age:52 ± 17(SD) years; FEV1:76 ± 19(SD)%pred] completed the study (DPI-BUD:n = 16; HFA-BDP:n = 15). After 6 and 12 weeks, there were no significant changes in acinar or conductive ventilation heterogeneity, nor in mid-expiratory flow, RV/TLC, closing capacity, impulse oscillometry indices (resistance, reactance), bronchial NO production or alveolar NO, in either treatment arm. Asthma control was maintained in both arms. CONCLUSION: In stable asthma patients with small airways dysfunction under maintenance therapy, there is a residual functional abnormality in the lung periphery which is probably not eosinophilic in origin and cannot be normalized with the iCS formulations under study. ISRCTN17195095.
RCT Entities:
RATIONALE: Even in stable asthmapatients, acinar ventilation distribution can be abnormal, and we aimed to specifically maximize its reversibility by switching patients from a standard inhaled corticosteroid (iCS) to a fine particle iCS formulation. METHODS: For this prospective double-blind double-dummy randomized study, 66 stable asthmapatients under maintenance iCS (equivalent budesonide ≤ 800 μg/day) were screened for abnormal baseline acinar ventilation heterogeneity (Sacin). After a 3-week run-in period, 35 eligible patients were randomized to fine particle beclomethasone (HFA-BDP; Qvar Autohaler) or to budesonide (DPI-BUD; Pulmicort Turbohaler). Asthma Control Test (ACT) score and various lung function indices reflecting the small airways were obtained at baseline, after 6 and 12 weeks. RESULTS: Thirty one patients [age:52 ± 17(SD) years; FEV1:76 ± 19(SD)%pred] completed the study (DPI-BUD:n = 16; HFA-BDP:n = 15). After 6 and 12 weeks, there were no significant changes in acinar or conductive ventilation heterogeneity, nor in mid-expiratory flow, RV/TLC, closing capacity, impulse oscillometry indices (resistance, reactance), bronchial NO production or alveolar NO, in either treatment arm. Asthma control was maintained in both arms. CONCLUSION: In stable asthmapatients with small airways dysfunction under maintenance therapy, there is a residual functional abnormality in the lung periphery which is probably not eosinophilic in origin and cannot be normalized with the iCS formulations under study. ISRCTN17195095.
Authors: Stacey R Boser; Thais Mauad; Bianca Bergamo de Araújo-Paulino; Ian Mitchell; Grishma Shrestha; Andrea Chiu; John Butt; Margaret M Kelly; Elia Caldini; Alan James; Francis H Y Green Journal: PLoS One Date: 2017-08-07 Impact factor: 3.240