Elsevier

Respiratory Medicine

Volume 102, Issue 8, August 2008, Pages 1099-1108
Respiratory Medicine

Effect of fluticasone propionate/salmeterol (250/50 μg) or salmeterol (50 μg) on COPD exacerbations

https://doi.org/10.1016/j.rmed.2008.04.019Get rights and content
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Summary

Objectives

COPD exacerbations are associated with significant morbidity and mortality. This randomized, double-blind, parallel-group, multicenter study evaluated the effect of fluticasone propionate/salmeterol 250/50 and salmeterol 50 μg twice daily on moderate to severe exacerbations.

Methods

Patients received standardized treatment with fluticasone propionate/salmeterol 250/50 during a 1-month run-in, followed by randomization to fluticasone propionate/salmeterol 250/50 or salmeterol for 12 months. Moderate to severe exacerbations were defined as worsening symptoms of COPD requiring treatment with oral corticosteroids, antibiotics, or hospitalization.

Results

In 782 patients with COPD (mean FEV1 = 0.94 ± 0.36 L, 33% predicted normal), treatment with fluticasone propionate/salmeterol 250/50 significantly reduced (1) the annual rate of moderate to severe exacerbations by 30.5% compared with salmeterol (1.06 and 1.53 per subject per year, respectively, p < 0.001), (2) the risk of time to first exacerbation by 25% (hazard ratio = 0.750, p = 0.003) and (3) the annual rate of exacerbations requiring oral corticosteroids by 40% (p < 0.001). Clinical improvements observed during run-in treatment with fluticasone propionate/salmeterol 250/50 were better maintained over 12 months with fluticasone propionate/salmeterol 250/50 than salmeterol. Adverse events were reported for a similar percentage of subjects across groups. A higher reporting of pneumonia was observed with fluticasone propionate/salmeterol 250/50 than salmeterol (7% vs. 4%).

Conclusions

We conclude that fluticasone propionate/salmeterol 250/50 is more effective than salmeterol at reducing the rate of moderate to severe exacerbations over 1 year. The benefits of this reduction relative to the risk of a higher incidence of reported pneumonia should be considered. This study supports the use of fluticasone propionate/salmeterol 250/50 for the reduction of COPD exacerbations in patients with COPD.

Keywords

Chronic obstructive pulmonary disease (COPD)
Salmeterol
Fluticasone propionate
Long-acting beta2-agonist
Inhaled corticosteroid
Exacerbations

Abbreviations

COPD
chronic obstructive pulmonary disease
FEV1
forced expiratory volume in one second
FSC
fluticasone propionate/salmeterol combination
FVC
forced vital capacity

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ClinicalTrials.gov identifier # NCT00144911.