| Comparable spirometric efficacy of tiotropium compared with salmeterol plus fluticasone in patients with COPD: a pilot study. | |
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MedLine Citation:
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PMID: 17118684 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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E D Bateman; M van Dyk; A Sagriotis |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2006-10-13 |
Journal Detail:
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Title: Pulmonary pharmacology & therapeutics Volume: 21 ISSN: 1094-5539 ISO Abbreviation: Pulm Pharmacol Ther Publication Date: 2008 |
Date Detail:
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Created Date: 2008-01-15 Completed Date: 2008-05-01 Revised Date: 2010-12-02 |
Medline Journal Info:
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Nlm Unique ID: 9715279 Medline TA: Pulm Pharmacol Ther Country: England |
Other Details:
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Languages: eng Pagination: 20-5 Citation Subset: IM |
Affiliation:
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Division of Pulmonology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, PO Box 34560, Groote Schuur 7937, Cape Town, South Africa. ebateman@uctgsh1.uct.ac.za <ebateman@uctgsh1.uct.ac.za> |
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Albuterol / analogs & derivatives*, therapeutic use Androstadienes / therapeutic use* Bronchodilator Agents / therapeutic use* Double-Blind Method Drug Administration Schedule Drug Combinations Female Humans Male Middle Aged Pilot Projects Pulmonary Disease, Chronic Obstructive / drug therapy* Respiratory Function Tests Scopolamine Derivatives / therapeutic use* |
| Chemical | |
Reg. No./Substance:
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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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