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. Double-blind randomized crossover trial with
COPD subjects receiving
Fluticasone/ Salmeterol 500 microg/50 microg (Flu/Sal) 1 puff twice daily and 2 puffs of
Albuterol Sulfate (90 microg micrograms per inhalation) or 2 puffs of
Albuterol (90 microg/puff and
Ipratropium Bromide 18 microg/puff. Either
Albuterol Sulfate (90 micrograms/puff) or Alb (90 micrograms/puff)/IB used prn for 3 weeks before crossing over to the other rescue formulation. This is a non-inferiority study where safety and efficacy outcomes were serially assessed, including adverse events, Baseline (BDI)/Transition
Dyspnea Index (TDI), St. George Respiratory Questionnaire (SGRQ), SF36, diary cards, 24-hour cardiac monitoring,
potassium and
glucose levels and other adverse events. Twenty subjects completed the study. The mean age was 62.5 (+/- 14.5); 12 were males. 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.