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Efficacy of Advair Diskus 250/50 (Fluticasone Propionate/Salmeterol) or Ipratropium/Albuterol in Patients with COPD Associated with Chronic Bronchitis and/or Emphysema

University of Pittsburgh, Pittsburgh, PA

PURPOSE: Advair 250/50 via Diskus in COPD has been studied primarily in patients with COPD associated with chronic bronchitis (CB). This post hoc analysis evaluated treatment effects in patients with CB + emphysema or emphysema alone.

METHODS: Two multicenter, randomized, double-blind studies comparing the efficacy and safety of Advair 250/50 BID with ipratropium/albuterol 36/206 mcg QID (IB/ALB) over 8 weeks. Patients were identified by study investigators as having COPD associated with CB, emphysema, or both.

RESULTS: Patients had similar mean baseline characteristics, including age (63-66 years), FEV1 (1.24-1.33 L; 42-44% predicted), FEV1/FVC ratio (0.50-0.52) and reversibility to albuterol (16.6-18.4%). After 8 weeks of treatment, patients with emphysema had a lower response in predose FEV1 to Advair 250/50. For Advair 250/50, all other efficacy parameters were similar regardless of COPD type. The responses to IB/ALB were more variable between disease types.

CONCLUSION: Patients with emphysema generally had the same response to Advair 250/50 as did those with CB or mixed disease, with the exception of a small difference in predose FEV1.

CLINICAL IMPLICATIONS: These data show that Advair and IB/ALB are efficacious regardless of type of COPD; Advair 250/50 provided greater efficacy in both groups compared with IB/ALB.
Mean Change (s.e.) From Baseline at Endpoint

CB + Emphysema Emphysema Advair 250/50 (n=209) IB/ALB (n=192) Advair 250/50 (n=142) IB/ALB (n=156) Predose FEV1 (mL) 132.6 (16.8)* -1.8 (15.4) 93.6 (20.8)* -4.9 (15.9) 6hr Serial FEV1 AUC (L-hr) (Week 8–Day 1) 0.36 (0.084)* -0.14 (0.70) 0.30 (0.093)* -0.30 (0.077) AM PEF (L/min) 36.2 (3.9)* 3.6 (3.0) 36.9 (6.0)* 7.7 (4.0) Predose Forced Vital Capacity (FVC) 160.6 (25.6)* 18.6 (25.4) 135.5 (33.0)* 15.6 (29.9) 6hr Serial FVC AUC (L-hr) (Week 8–Day 1) 0.27 (0.138)* -0.34 (0.119) 0.16 (0.149)* -0.35 (0.146) Dyspnea Score (TDI) 2.8 (0.2)* 1.4 (0.2) 2.4 (0.3)* 1.3 (0.3) Daytime Symptom Score (0-400 Scale) -51.6 (5.5)* -24.3 (4.9) -48.5 (6.1) -44.0 (5.3) % Symptom-Free Nights 26.2 (3.5)* 6.3 (2.7) 21.7 (3.9)* 11.7 (3.1) % Rescue-Free Days 35.5 (3.1)* 28.0 (3.0) 36.3 (3.9)* 25.3 (3.4)

^* p<0.047 for Advair 250/50 vs IB/ALB within subgroup

DISCLOSURE: F.C. Sciurba, None.