Abstract
This randomized controlled trial examined the benefits of combining an inhaled corticosteroid, fluticasone propionate (F), with an inhaled long-acting beta(2)-agonist, salmeterol (S), to treat the inflammatory and bronchoconstrictive components of chronic obstructive pulmonary disease (COPD). A total of 691 patients with COPD received the combination of F and S (FSC), S (50 mcg), F (500 mcg), or placebo twice daily via the Diskus device for 24 weeks. A significantly greater increase in predose FEV(1) at the endpoint was observed after FSC (156 ml) compared with S (107 ml, p = 0.012) and placebo (-4 ml, p < 0.0001). A significantly greater increase in 2-hour postdose FEV(1) at the endpoint was observed after treatment with FSC (261 ml) compared with F (138 ml, p < 0.001) and placebo (28 ml, p < 0.001). There were greater improvements in the Transition Dyspnea Index with FSC (2.1) compared with F (1.3, p = 0.033), S (0.9, p < 0.001), and placebo (0.4, p < 0.0001). The incidence of adverse effects (except for an increase in oral candidiasis with FSC and F) was similar among the treatment groups. We conclude that FSC improved lung function and reduced the severity of dyspnea compared with individual components and placebo.
Publication types
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Clinical Trial
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Multicenter Study
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Randomized Controlled Trial
MeSH terms
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Administration, Inhalation
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Administration, Topical
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Adrenergic beta-Agonists / administration & dosage*
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Adrenergic beta-Agonists / adverse effects
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Adult
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Aged
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Aged, 80 and over
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Albuterol / administration & dosage*
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Albuterol / adverse effects
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Albuterol / analogs & derivatives*
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Albuterol / therapeutic use*
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Androstadienes / administration & dosage*
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Androstadienes / adverse effects
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Androstadienes / therapeutic use*
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Anti-Inflammatory Agents / administration & dosage*
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Anti-Inflammatory Agents / adverse effects
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Bronchodilator Agents / administration & dosage*
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Bronchodilator Agents / adverse effects
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Double-Blind Method
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Drug Combinations
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Female
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Fluticasone
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Fluticasone-Salmeterol Drug Combination
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Forced Expiratory Volume
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Glucocorticoids
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Humans
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Male
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Middle Aged
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Nebulizers and Vaporizers
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Peak Expiratory Flow Rate
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Powders
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Pulmonary Disease, Chronic Obstructive / drug therapy*
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Pulmonary Disease, Chronic Obstructive / physiopathology
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Salmeterol Xinafoate
Substances
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Adrenergic beta-Agonists
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Androstadienes
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Anti-Inflammatory Agents
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Bronchodilator Agents
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Drug Combinations
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Fluticasone-Salmeterol Drug Combination
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Glucocorticoids
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Powders
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Salmeterol Xinafoate
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Fluticasone
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Albuterol