PURPOSE: The purpose of this study is to evaluate the nebulization requirements, costs of therapy, and chronotropic effects of levalbuterol versus albuterol in adult hospitalized patients with exacerbation of chronic obstructive pulmonary disease (COPD) or asthma.
METHODS: X-ACT is a single-center, randomized, prospective, open-label study. Eligible and consenting patients are stratified by COPD or asthma exacerbation and randomized 1:1 to receive either albuterol 2.5 mg (ALB) four times daily or levalbuterol 1.25 mg (LEV) three times daily via high flow nebulization. All patients are also placed on ALB via nebulization every 4 hours as needed for dyspnea or wheezing. Primary outcome measures include: the number of scheduled and rescue nebulizations required and costs associated with therapy. Secondary outcomes include change in heart rate (HR) from baseline. A target enrollment of 130 patients is required to obtain 80% power at an alpha level of 0.05.
RESULTS: A total of 91 patients (LEV=48; ALB=43) meeting inclusion criteria are included in the interim results. The groups were well matched and included a substantial proportion of patients with cardiovascular disease (LEV=54.2%, ALB=38%; p=0.13). Overall, the mean age was 64 years and 58% of patients were female. There were no significant differences between patients treated with LEV versus ALB in total scheduled nebulizations administered (19.4 ± 2.0; 22.0 ± 2.2; p = 0.39) and rescue nebulizations required (0.54 ± 0.13; 1.0 ± 0.4; p = 0.22). In terms of mean largest HR increase from baseline, there were no differences between LEV and ALB (10.4 ± 1.8 bpm; 8.4 ± 1.0 bpm; p=0.36). Similarly, there were no differences in mean largest HR increase from baseline in patients with a history of cardiovascular disease (7.7 ± 0.9 bpm; 8.9 ± 1.4 bpm; p=0.45).
CONCLUSIONS: Interim results suggest there are no significant differences between LEV and ALB in terms of rescue nebulization requirements and beta-agonist mediated chronotropic effects. Data collection and analysis is ongoing. Final analysis will include costs of therapy.
CLINICAL IMPLICATIONS: The current analysis does not support any advantages of LEV over ALB in terms of reduced rescue nebulizations or beta-mediated chronotropism.
DISCLOSURE: The following authors have nothing to disclose: George Poiani, Luigi Brunetti, Fatema Dhanaliwala
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