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Maintenance of Bronchodilator Response for Advair Diskus 250/50 (Fluticasone Propionate/Salmeterol) but not Ipratropium/Albuterol in Patients with COPD

GlaxoSmithKline, Raleigh, NC

PURPOSE: The bronchodilator response for Advair 250/50 was compared with ipratropium/albuterol (IB/ALB) via metered-dose inhaler. This comparison was performed to determine if these treatments differed in the maintenance of bronchodilator efficacy following repeat dosing in COPD patients.

METHODS: A post-hoc analysis of FEV1 data from two randomized, double-blind, parallel-group multicenter trials comparing Advair 250/50 BID and IB/ALB 36/206mcg QID in patients with COPD (n=602) was performed. Six hour serial spirometry was performed after the first (Day 1) and last (Week 8) dose of study medication. Spirometry was conducted pre-dose and at 0.5, 1.0, 2.0, 4.0, and 6.0hr post-dose. Mean bronchodilator response at Week 8 was compared to the Day 1 response for all patients who completed the study.

RESULTS: The mean FEV1AUC0-6hr for Advair 250/50 significantly increased from 1.06L-hr at Day 1 to 1.39L-hr at Week 8 (p<0.001). For IB/ALB, the mean FEV1AUC0-6hr significantly decreased from 1.16L-hr to 0.95L-hr (p<0.001). The FVC AUC0-6hr for Advair 250/50 increased from 1.69L-hr to 1.91L-hr (p<0.027) compared with a decrease from 2.03L-hr to 1.69L-hr with IB/ALB (p<0.001). The Week 8 FEV1 and FVC AUC0-6 values for Advair 250/50 were significantly greater than those for IB/ALB (p=0.027), while Day 1 values were not significantly different. Changes in FEV1 responses from Day 1 to Week 8 are shown below. At individual time points over the 6hr, mean increases in serial FEV1 values for Advair 250/50 from Day 1 to Week 8 ranged from 35 to 83mL compared with decreases of –55 to -8mL for IB/ALB.

CONCLUSION: After 8 weeks of treatment, a significant increase in bronchodilator response was observed with Advair 250/50 but not IB/ALB in patients with COPD.

CLINICAL IMPLICATIONS: Use of a beta-agonist in combination with an inhaled corticosteroid maintains or enhances bronchodilator efficacy, while a loss of bronchodilator efficacy is observed when combined with an anticholinergic.
Change in FEV₁ From Day 1 to Week 8

FSC (n=303) IB/ALB (N=299) Peak FEV1 change from baseline, mL 51.5 (18.3%) -17.7 (-5.4%) FEV1AUC0–6, L-hr 0.33 (22.7%) -0.22 (-14.2%) FEV1AUC0–4, L-hr 0.25 (24.6%) -0.11 (-10.9%) FEV1AUC0–2, L-hr 0.15 (26.7%) -0.03 (-5.9%)

DISCLOSURE: K. Knobil, None.