Document Detail

Comparable spirometric efficacy of tiotropium compared with salmeterol plus fluticasone in patients with COPD: a pilot study.
MedLine Citation:
PMID:  17118684     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: International guidelines recommend the long-acting anticholinergic, tiotropium, or long-acting beta 2-agonists as maintenance therapy in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). The efficacy of long-acting beta(2)-agonists combined with inhaled corticosteroids (ICS) in the treatment of COPD has also been confirmed for severe and very severe COPD, but data comparing tiotropium with the combination of a long-acting beta 2-agonist and an ICS are lacking.
METHODS: This 6-week multicentre, randomised, double-blind, triple-dummy pilot study compared the bronchodilator effects of tiotropium 18 microg once daily (n=56) vs. the combination of salmeterol 50 microg plus fluticasone 250 microg twice daily (n=51) in patients with moderate-to-very severe COPD. Serial spirometry was performed over 12h after 6 weeks of treatment. The primary endpoint was forced expiratory volume in 1s (FEV1) area under the curve from 0 to 12h (AUC0-12h) on Day 43.
RESULTS: Randomization failed to provide treatment groups with comparable baseline characteristics for smoking history, current smokers, duration of COPD, FEV1, forced vital capacity (FVC) and reversibility. Mean+/-SD FEV1 was 1.31+/-0.47 l in the tiotropium group vs. 1.46+/-0.53 l in the salmeterol plus fluticasone group. Fewer patients in the tiotropium showed a 12% and 200 ml acute increase to short-acting bronchodilators at baseline. However, treatment with tiotropium alone resulted in comparable bronchodilation compared with salmeterol plus fluticasone, as measured by all the spirometric parameters at the end of the 6-week study period. FEV1 AUC0-12h was 1.55+/-0.03 l in the tiotropium group vs. 1.57+/-0.04 l in the salmeterol plus fluticasone groups (p=0.63). Trough (predose) FEV1 was 1.54+/-0.03 l in the tiotropium group vs. 1.46+/-0.03 l in the combination group (p=0.07), and peak FEV(1) was 1.68+/-0.04 l vs. 1.66+/-0.04 l, respectively, (p=0.77). FVC AUC0-12h, trough and peak were also comparable between groups at study end (p>0.05, for all). Further, rescue salbutamol use was similar in the tiotropium and combination groups and both treatment regimens were well tolerated.
CONCLUSIONS: Six weeks of treatment with tiotropium resulted in comparable bronchodilation compared with salmeterol plus fluticasone in patients with moderate-to-very severe COPD, despite tiotropium patients having lower lung function and fewer patients considered reversible at baseline. The results of this pilot study will aid planning for further large-scale comparative studies.
E D Bateman; M van Dyk; A Sagriotis
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-10-13
Journal Detail:
Title:  Pulmonary pharmacology & therapeutics     Volume:  21     ISSN:  1094-5539     ISO Abbreviation:  Pulm Pharmacol Ther     Publication Date:  2008  
Date Detail:
Created Date:  2008-01-15     Completed Date:  2008-05-01     Revised Date:  2010-12-02    
Medline Journal Info:
Nlm Unique ID:  9715279     Medline TA:  Pulm Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  20-5     Citation Subset:  IM    
Division of Pulmonology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, PO Box 34560, Groote Schuur 7937, Cape Town, South Africa. <>
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MeSH Terms
Albuterol / analogs & derivatives*,  therapeutic use
Androstadienes / therapeutic use*
Bronchodilator Agents / therapeutic use*
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Middle Aged
Pilot Projects
Pulmonary Disease, Chronic Obstructive / drug therapy*
Respiratory Function Tests
Scopolamine Derivatives / therapeutic use*
Reg. No./Substance:
0/Androstadienes; 0/Bronchodilator Agents; 0/Drug Combinations; 0/Scopolamine Derivatives; 0/fluticasone, salmeterol drug combination; 136310-93-5/tiotropium; 18559-94-9/Albuterol

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