PURPOSE:We conducted a randomized, open-label, crossover trial to evaluate bronchodilation and patient treatment satisfaction with twice-daily nebulized formoterol fumarate versus 4-times daily ipratropium/albuterol by metered-dose inhaler (MDI).
METHODS:After a 7-day screening period, subjects with COPD (n=109, 52.8% predicted FEV1) and no significant comorbidities were randomized to receive formoterol fumarate inhalation solution (FFIS 20 μg) twice-daily by nebulization or ipratropium bromide/albuterol sulfate combination by MDI (IPR/ALB 18/103 μg) 4-times daily for 2 weeks. Following a 1-week washout period, subjects crossed over to receive the other medication. Efficacy was assessed by spirometry at the start and end of each 2-week period, the transition dyspnea index, and a treatment satisfaction/preference survey.
RESULTS:At Day 14, mean morning pre-dose (trough) FEV1 was greater in the FFIS group (1.418 L) than the IPR/ALB group (1.319 L) (p<0.001). Peak FEV1and standardized FEV1 AUC0–6 were similar between groups. Both FFIS and IPR/ALB treatments provided clinically meaningful improvements in dyspnea scores. Treatment satisfaction and the perception of disease control were greater during FFIS treatment (p<0.05) than with IPR/ALB treatment.
CONCLUSION:Nebulized FFIS treatment provided bronchodilation comparable to IPR/ALB with significantly prolonged duration of action leading to improved morning pre-dose FEV1 in COPD subjects. Twice daily nebulized treatment also provided a perception of increased control over their lung disease, and increased treatment satisfaction compared to 4-times daily MDI combination therapy.
CLINICAL IMPLICATIONS:A twice-daily regimen of nebulized formoterol fumarate provides superior morning bronchodilation and increased patient preference versus 4-times-daily IPR/ALB in COPD treatment.
DISCLOSURE:Kimberly Denis-Mize, No Financial Disclosure Information; No Product/Research Disclosure Information