The following is a summary of “Atomization efficacy of a novel micro-dose mesh nebulizer (CVS-100) versus the traditional mesh nebulizer (M102) in adults with chronic obstructive pulmonary disease: A randomized non-inferiority clinical trial,” published in the November 2023 issue of Pulmonology by Qu, et al.
For a study, researchers sought to assess the atomization efficacy of a new micro-dose mesh nebulizer (CVS-100) in comparison to a traditional mesh nebulizer (M102) when nebulizing a combination of ipratropium bromide and salbutamol for treating stable moderate-to-severe chronic obstructive pulmonary disease (COPD).
Conducted as a randomized, parallel, non-inferiority trial, 64 stable COPD patients were randomly assigned to the experimental group (CVS-100) or the control group (M102) in a 1:1 ratio. Both groups received nebulized Combivent. Lung function was measured before and 30 minutes after nebulization, assessing the percentage of forced expiratory volume in the first second (FEV1%pred), forced expiratory flow at 50% (FEF50%), forced expiratory flow at 75% (FEF75%), mid-expiratory flow (FEF25-75%), and maximal voluntary ventilation (MVV). The non-inferiority margin for the lower 95% confidence limit was 3.5%.
The lower limit of the 95% CI for the difference in FEV1%pred between the groups was −1.83357, exceeding the defined non-inferiority margin of −3.5. No significant differences were observed in FEF50%, FEF75%, FEF25∼75%, and MVV before and after nebulization between the two nebulizer groups.
The novel micro-dose mesh nebulizer (CVS-100) demonstrated non-inferiority to the traditional mesh nebulizer (M102) regarding changes in FEV1%pred from baseline after nebulization. Comparable results were found for all other efficacy measures.