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The lung function profile of once-daily tiotropium and olodaterol via Respimat(®) is superior to that of twice-daily salmeterol and fluticasone propionate via Accuhaler(®) (ENERGITO(®) study).

Beeh, Kai-Michael; Derom, Eric; Echave-Sustaeta, José; Grönke, Lars; Hamilton, Alan; Zhai, Dongmei and Bjermer, Leif LU (2016) In The International Journal of Chronic Obstructive Pulmonary Disease 11. p.193-205
Abstract
BACKGROUND:



Tiotropium + olodaterol has demonstrated improvements beyond lung function benefits in a large Phase III clinical program as a once-daily maintenance treatment for COPD and may be a potential option for the initiation of maintenance treatment in COPD. Despite guideline recommendations that combined long-acting β2-agonists and inhaled corticosteroids should only be used in individuals at high risk of exacerbation, there is substantial use in individuals at lower risk. This raises the question of the comparative effectiveness of this combination as maintenance treatment in this group compared to other combination regimens.

OBJECTIVE:



The study aimed to assess the effect on lung... (More)
BACKGROUND:



Tiotropium + olodaterol has demonstrated improvements beyond lung function benefits in a large Phase III clinical program as a once-daily maintenance treatment for COPD and may be a potential option for the initiation of maintenance treatment in COPD. Despite guideline recommendations that combined long-acting β2-agonists and inhaled corticosteroids should only be used in individuals at high risk of exacerbation, there is substantial use in individuals at lower risk. This raises the question of the comparative effectiveness of this combination as maintenance treatment in this group compared to other combination regimens.

OBJECTIVE:



The study aimed to assess the effect on lung function of once-daily tiotropium + olodaterol versus twice-daily salmeterol + fluticasone propionate in all participants with Global initiative for chronic Obstructive Lung Disease 2 or 3 (moderate to severe) COPD.

METHODS:



This was a randomized, double-blind, double-dummy, four-treatment, complete crossover study in which participants received once-daily tiotropium + olodaterol (5/5 µg and 2.5/5 µg) via Respimat(®) and twice-daily salmeterol + fluticasone propionate (50/500 µg and 50/250 µg) via Accuhaler(®) for 6 weeks. The primary end point was change in forced expiratory volume in 1 second (FEV1) area under the curve from 0 hour to 12 hours (AUC0-12) relative to the baseline after 6 weeks.

RESULTS:



Tiotropium + olodaterol 5/5 µg and 2.5/5 µg demonstrated statistically significant improvements in FEV1 AUC0-12 compared to salmeterol + fluticasone propionate (improvements from baseline were 317 mL and 295 mL with tiotropium + olodaterol 5/5 µg and 2.5/5 µg, and 188 mL and 192 mL with salmeterol + fluticasone propionate 50/500 µg and 50/250 µg, respectively). Tiotropium + olodaterol was superior to salmeterol + fluticasone propionate in lung function secondary end points, including FEV1 area under the curve from 0 hour to 24 hours (AUC0-24).

CONCLUSION:



Once-daily tiotropium + olodaterol in participants with moderate-to-severe COPD provided superior lung function improvements to twice-daily salmeterol + fluticasone propionate. Dual bronchodilation can be considered to optimize lung function in individuals requiring maintenance treatment for COPD. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
The International Journal of Chronic Obstructive Pulmonary Disease
volume
11
pages
193 - 205
publisher
Dove Press
external identifiers
  • pmid:26893551
  • scopus:84957094801
  • wos:000370084900001
ISSN
1178-2005
DOI
10.2147/COPD.S95055
language
English
LU publication?
yes
id
6787799d-5631-4f96-88e7-35c0cae1bfcf (old id 8825036)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/26893551?dopt=Abstract
date added to LUP
2016-03-03 13:18:00
date last changed
2017-07-30 03:23:56
@article{6787799d-5631-4f96-88e7-35c0cae1bfcf,
  abstract     = {BACKGROUND:<br/><br>
<br/><br>
Tiotropium + olodaterol has demonstrated improvements beyond lung function benefits in a large Phase III clinical program as a once-daily maintenance treatment for COPD and may be a potential option for the initiation of maintenance treatment in COPD. Despite guideline recommendations that combined long-acting β2-agonists and inhaled corticosteroids should only be used in individuals at high risk of exacerbation, there is substantial use in individuals at lower risk. This raises the question of the comparative effectiveness of this combination as maintenance treatment in this group compared to other combination regimens.<br/><br>
OBJECTIVE:<br/><br>
<br/><br>
The study aimed to assess the effect on lung function of once-daily tiotropium + olodaterol versus twice-daily salmeterol + fluticasone propionate in all participants with Global initiative for chronic Obstructive Lung Disease 2 or 3 (moderate to severe) COPD.<br/><br>
METHODS:<br/><br>
<br/><br>
This was a randomized, double-blind, double-dummy, four-treatment, complete crossover study in which participants received once-daily tiotropium + olodaterol (5/5 µg and 2.5/5 µg) via Respimat(®) and twice-daily salmeterol + fluticasone propionate (50/500 µg and 50/250 µg) via Accuhaler(®) for 6 weeks. The primary end point was change in forced expiratory volume in 1 second (FEV1) area under the curve from 0 hour to 12 hours (AUC0-12) relative to the baseline after 6 weeks.<br/><br>
RESULTS:<br/><br>
<br/><br>
Tiotropium + olodaterol 5/5 µg and 2.5/5 µg demonstrated statistically significant improvements in FEV1 AUC0-12 compared to salmeterol + fluticasone propionate (improvements from baseline were 317 mL and 295 mL with tiotropium + olodaterol 5/5 µg and 2.5/5 µg, and 188 mL and 192 mL with salmeterol + fluticasone propionate 50/500 µg and 50/250 µg, respectively). Tiotropium + olodaterol was superior to salmeterol + fluticasone propionate in lung function secondary end points, including FEV1 area under the curve from 0 hour to 24 hours (AUC0-24).<br/><br>
CONCLUSION:<br/><br>
<br/><br>
Once-daily tiotropium + olodaterol in participants with moderate-to-severe COPD provided superior lung function improvements to twice-daily salmeterol + fluticasone propionate. Dual bronchodilation can be considered to optimize lung function in individuals requiring maintenance treatment for COPD.},
  author       = {Beeh, Kai-Michael and Derom, Eric and Echave-Sustaeta, José and Grönke, Lars and Hamilton, Alan and Zhai, Dongmei and Bjermer, Leif},
  issn         = {1178-2005},
  language     = {eng},
  pages        = {193--205},
  publisher    = {Dove Press},
  series       = {The International Journal of Chronic Obstructive Pulmonary Disease},
  title        = {The lung function profile of once-daily tiotropium and olodaterol via Respimat(®) is superior to that of twice-daily salmeterol and fluticasone propionate via Accuhaler(®) (ENERGITO(®) study).},
  url          = {http://dx.doi.org/10.2147/COPD.S95055},
  volume       = {11},
  year         = {2016},
}