Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI *.
Author(s): Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K
Affiliation(s): aNational Jewish Health, Denver, CO, USA, bInstitute of HealthCare Assessment, Inc., San Diego, CA, USA, cSouth Carolina Pharmaceutical Research, Spartanburg, SC, USA, dDey LP, Napa, CA, USA.
Publication date & source: 2009-03, Curr Med Res Opin., 25(3):653-61.
ABSTRACT Objective: Bronchodilator maintenance treatment improves pulmonary function and health-related quality of life in COPD patients. Pulmonary function and patient preference/satisfaction were compared before and after treatment with a short-acting ipratropium/albuterol combination and long-acting nebulized formoterol. Methods: A randomized, open-label, crossover trial was conducted at 16 centers in the US. COPD subjects (n = 109, 52.8% predicted FEV(1)) received nebulized formoterol fumarate inhalation solution (Perforomist**, FFIS 20 mug BID) or ipratropium and albuterol combined in a metered-dose inhaler (MDI) (Combivent dagger , IPR-ALB, QID) for 2 weeks. After a 1-week washout, subjects were crossed over to the other treatment. Efficacy was assessed with 6-h pulmonary function tests and the transition dyspnea index (TDI). Treatment satisfaction and preference were assessed after treatment. Post-hoc subgroup analyses were conducted by age, gender and COPD severity. ** Perforomist is a registered trademark name of Dey LP, Napa, CA, USA dagger Combivent is a registered trademark of Boehringer Ingelheim, Ridgefield, CT, USA Main outcome measure: Morning pre-dose FEV(1) (trough) after 2 weeks of treatment. Results: FFIS significantly increased morning pre-dose FEV(1) relative to IPR-ALB (p = 0.0015). FFIS also improved pre-dose FEV(1) beyond that of IPR-ALB in subjects who were older (>/=65 years), male, and with both moderate and severe/very severe COPD. Post-dose efficacy at 6 h was maintained in the FFIS group compared with IPR-ALB (p </= 0.0001). Patient satisfaction and the perception of disease control were significantly greater with FFIS in the older, male, and severe subgroups. Severe subjects preferred FFIS to IPR-ALB. Both FFIS and IPR-ALB treatments resulted in clinically meaningful changes in dyspnea, but no significant differences were observed between treatments. Conclusions: Following a 2-week treatment period, twice-daily nebulized FFIS was significantly more effective in improving lung function than the IPR-ALB combination MDI delivered four times daily. Although the open-label design may limit interpretation of pulmonary function, the crossover design enabled demonstration of greater treatment satisfaction and perception of disease control following nebulized FFIS treatment. Clinical trial registration: Clinicaltrials.gov NCT00462540.