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Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4).

Buhl, Roland; Maltais, François; Abrahams, Roger; Bjermer, Leif LU ; Derom, Eric; Ferguson, Gary; Fležar, Matjaž; Hébert, Jacques; McGarvey, Lorcan and Pizzichini, Emilio, et al. (2015) In European Respiratory Journal 45(4). p.969-979
Abstract
Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0-3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6)... (More)
Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0-3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0-3 and trough FEV1 response versus the mono-components in both studies. Statistically significant improvements in SGRQ total score versus the mono-components were only seen for tiotropium+olodaterol FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the mono-components. These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+olodaterol FDC versus mono-components over 1 year in patients with moderate to very severe COPD. (Less)
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European Respiratory Journal
volume
45
issue
4
pages
969 - 979
publisher
Eur Respiratory Soc
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  • pmid:25573406
  • wos:000352023800011
  • scopus:84926500092
ISSN
1399-3003
DOI
10.1183/09031936.00136014
language
English
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b7209521-0c67-485e-bfdc-6d921224ef15 (old id 5040910)
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http://www.ncbi.nlm.nih.gov/pubmed/25573406?dopt=Abstract
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2015-02-02 20:51:03
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@article{b7209521-0c67-485e-bfdc-6d921224ef15,
  abstract     = {Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0-3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0-3 and trough FEV1 response versus the mono-components in both studies. Statistically significant improvements in SGRQ total score versus the mono-components were only seen for tiotropium+olodaterol FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the mono-components. These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+olodaterol FDC versus mono-components over 1 year in patients with moderate to very severe COPD.},
  author       = {Buhl, Roland and Maltais, François and Abrahams, Roger and Bjermer, Leif and Derom, Eric and Ferguson, Gary and Fležar, Matjaž and Hébert, Jacques and McGarvey, Lorcan and Pizzichini, Emilio and Reid, Jim and Veale, Antony and Grönke, Lars and Hamilton, Alan and Korducki, Lawrence and Tetzlaff, Kay and Waitere-Wijker, Stella and Watz, Henrik and Bateman, Eric},
  issn         = {1399-3003},
  language     = {eng},
  number       = {4},
  pages        = {969--979},
  publisher    = {Eur Respiratory Soc},
  series       = {European Respiratory Journal},
  title        = {Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4).},
  url          = {http://dx.doi.org/10.1183/09031936.00136014},
  volume       = {45},
  year         = {2015},
}