Document Detail

Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease.
MedLine Citation:
PMID:  17053207     Owner:  NLM     Status:  MEDLINE    
RATIONALE: Exacerbations of chronic obstructive pulmonary disease (COPD) greatly contribute to declining health status and the progression of the disease, thereby incurring significant direct and indirect health care costs. The prevention of exacerbations, therefore, is an important treatment goal. OBJECTIVES: To assess the impact of combination therapy with salmeterol/fluticasone propionate compared with salmeterol alone on moderate and severe exacerbations in patients with severe COPD and a history of repeated exacerbations. METHODS: Randomized, double-blind, parallel-group study. After a 4-wk run-in period, 994 clinically stable patients were randomized to one of two treatment groups: 507 patients received the salmeterol/fluticasone combination 50/500 micro g twice daily and 487 received salmeterol 50 micro g twice daily for 44 wk. MAIN RESULTS: The total number of exacerbations was 334 in the combination therapy and 464 in the salmeterol group (p < 0.0001). The annualized rate of moderate and severe exacerbations per patient was 0.92 in the combination therapy and 1.4 in the salmeterol group, corresponding to a 35% decrease. In addition, the mean time to first exacerbation in the combination therapy group was significantly longer compared with that of the salmeterol group (128 vs. 93 d, p < 0.0001). Other endpoints, including health-related quality of life, peak expiratory flow, and use of rescue medication, were significantly improved in the combination therapy group. Both treatments were well tolerated. CONCLUSIONS: This study demonstrates that combination therapy with salmeterol/fluticasone compared with salmeterol monotherapy significantly reduces the frequency of moderate/severe exacerbations in patients with severe COPD.
Peter Kardos; Marion Wencker; Thomas Glaab; Claus Vogelmeier
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2006-10-19
Journal Detail:
Title:  American journal of respiratory and critical care medicine     Volume:  175     ISSN:  1073-449X     ISO Abbreviation:  Am. J. Respir. Crit. Care Med.     Publication Date:  2007 Jan 
Date Detail:
Created Date:  2007-01-03     Completed Date:  2007-03-12     Revised Date:  2007-10-09    
Medline Journal Info:
Nlm Unique ID:  9421642     Medline TA:  Am J Respir Crit Care Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  144-9     Citation Subset:  AIM; IM    
Group Practice and Center for Respiratory and Sleep Medicine, Allergy, Maingau Hospital, Scheffelstrasse 2, 60318 Frankfurt am Main, Germany.
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MeSH Terms
Albuterol / administration & dosage,  adverse effects,  analogs & derivatives*,  therapeutic use
Androstadienes / administration & dosage,  adverse effects,  therapeutic use*
Bronchodilator Agents / administration & dosage,  adverse effects,  therapeutic use*
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Lung / drug effects
Middle Aged
Pulmonary Disease, Chronic Obstructive / drug therapy*
Quality of Life
Reg. No./Substance:
0/Androstadienes; 0/Bronchodilator Agents; 18559-94-9/Albuterol; 89365-50-4/salmeterol; 90566-53-3/fluticasone
Comment In:
Am J Respir Crit Care Med. 2007 Jun 15;175(12):1347; author reply 1347-8   [PMID:  17545461 ]
Am J Respir Crit Care Med. 2007 Sep 1;176(5):522; author reply 522-3   [PMID:  17715385 ]
Am J Respir Crit Care Med. 2007 Jan 15;175(2):103-4   [PMID:  17200504 ]
Am J Respir Crit Care Med. 2007 Jun 1;175(11):1207; author reply 1207-8   [PMID:  17519347 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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