Abstract: Poster Presentations |

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

Frank C. Sciurba, MD*; Chris Kalberg, PhD; Amanda Emmett, MS; Kunal Merchant, PhD; Christy Brown, PharmD; Katharine Knobil, MD
Author and Funding Information

University of Pittsburgh, Pittsburgh, PA


Chest. 2004;126(4_MeetingAbstracts):807S-a-808S. doi:10.1378/chest.126.2_suppl_1.117S
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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 + EmphysemaEmphysemaAdvair 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 Nights26.2 (3.5)*6.3 (2.7)21.7 (3.9)*11.7 (3.1)% Rescue-Free Days35.5 (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.

Wednesday, October 27, 2004

12:30 PM - 2:00 PM




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