COPD
-
Randomized Controlled Trial Comparative Study
A double-blind crossover study comparing the safety and efficacy of three weeks of Flu/Sal 250/50 bid plus albuterol 180 ug prn q4 hours to Flu/Sal 250/50 bid plus albuterol/Ipratropium bromide 2 puffs prn q4 hours in patients with chronic obstructive pulmonary disease.
The Federal Drug Administration (FDA) approved the use of Fluticasone 250 microg/Salmeterol 50 microg 1 puff bid for maintenance therapy in patients with COPD associated with chronic bronchitis. Short-acting beta agonists (SABA) have been the recommended rescue medication; however, previous studies have shown that combination short-acting Albuterol (alb) /Ipratropium bromide (IB) has superior bronchodilator properties to albuterol alone in patients with COPD. The safety and efficacy of Albuterol compared to Albuterol/Ipratropium bromide as rescue medications for COPD patients on maintenance combination therapy of ICS/LABA has not been evaluated. ⋯ The mean baseline FEV(1) (range) was 1.12 L (0.56-1.67) or 40.6 (21-65)% predicted. There were no statistically significant differences between either rescue inhaler formulation with regard to measures neither of lung function or dyspnea nor in terms of safety parameters of cardiac monitoring, glucose and potassium levels and other adverse events. SABA and combination SABA/Ipratropium bromide are equally safe and efficacious as rescue inhalers for patients on combination Fluticasone 500 microg/Salmeterol 50 microg.