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 FEV1) received nebulized formoterol fumarate inhalation solution (Perforomist**, FFIS 20g BID) or ipratropium and albuterol combined in a metered-dose inhaler (MDI) (Combiventy, 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. MAIN OUTCOME MEASURE: Morning pre-dose FEV1 (trough) after 2 weeks of treatment. RESULTS: FFIS significantly increased morning pre-dose FEV1 relative to IPR-ALB (p = 0.0015). FFIS also improved pre-dose FEV1 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<or= 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.
RCT Entities:
OBJECTIVE: Bronchodilator maintenance treatment improves pulmonary function and health-related quality of life in COPDpatients. 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 FEV1) received nebulized formoterol fumarate inhalation solution (Perforomist**, FFIS 20g BID) or ipratropium and albuterol combined in a metered-dose inhaler (MDI) (Combiventy, 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. MAIN OUTCOME MEASURE: Morning pre-dose FEV1 (trough) after 2 weeks of treatment. RESULTS: FFIS significantly increased morning pre-dose FEV1 relative to IPR-ALB (p = 0.0015). FFIS also improved pre-dose FEV1 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<or= 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.