Determining when to begin therapy with a long-acting bronchodilator and inhaled corticosteroid in patients with COPD is challenging since no clinical trials have been conducted to specifically answer this question. This analysis was conducted to evaluate the efficacy of a long-acting bronchodilator, an anti-inflammatory agent, or the two together compared with placebo in patients previously not receiving maintenance COPD medications.
Data was obtained from a 24-week clinical trial comparing twice daily Advair 250/50 with fluticasone propionate (FP) 250mcg, salmeterol 50mcg or placebo in patients with COPD. Patients were at least 40 years of age, had at least a 20 pack year history of smoking, and had symptoms of chronic bronchitis.
Three hundred seventy-eight patients were previously naïve to COPD therapy. The patients had similar mean baseline characteristics, including age (61-63 years), FEV1 (1.28-1.38L; 43-45% predicted), Baseline Dyspnea Index (BDI; 5.7-6.6) and reversibility to albuterol (19.9-22.0%).
Advair 250/50 BID provided significant improvements in lung function when used as first line maintenance therapy in patients naïve to COPD maintenance medications. Improvements were also seen in TDI and CRDQ though they did not reach statistical significance.
These data, demonstrating the efficacy of initial maintenance therapy with Advair 250/50 in patients previously naïve to COPD maintenance therapy, are consistent with efficacy results seen in the overall study population (Hanania, Chest 2003). Mean Change From Baseline at Endpoint (SEM)Advair 250/50 (n=91)FP (n=101)Salmeterol (n=95)Placebo (n=91)Pre-dose FEV1, mL171 (29.9)*109 (26.7)86 (27.2)15 (23.0)2-Hour Post-dose FEV1, mL280 (32.0)†149 (26.7)209 (27.6)57 (24.0)Transition Dyspnea Index (TDI)2.0 (0.37)1.9 (0.31)1.3 (0.33)1.3 (0.38)Chronic Respiratory Disease Questionnaire (CRDQ)12.1 (1.85)13.0 (1.57)7.0 (1.87)7.9 (1.81)*
p<0.044 Advair vs Placebo, salmeterol;†
p<0.0068 Advair vs Placebo, FP
A.R. Anzueto, None.