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Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD

Worth, Heinrich; Forster, Karin; Eriksson, Göran LU ; Nihlén, Ulf LU ; Peterson, Stefan and Magnussen, Helgo (2010) In Respiratory Medicine 104(10). p.1450-1459
Abstract
Background: Breathlessness and exercise intolerance frequently impact the daily life of patients with COPD. Methods: This double-blind, multicentre, three-period crossover study randomised 111 patients with COPD (mean age 64 years, mean FEV1 38% of predicted normal) to budesonide/formoterol 320/9 mu g, formoterol 9 mu g or placebo, twice daily for 1 week, following a 1-week run-in period with 1-week wash-out between treatments. Terbutaline (0.5 mg/dose) was used as needed. The primary efficacy variable was exercise endurance time (EET) at 75% peak work capacity with cycle ergometry assessed 1 h post-morning dose. Results: Budesonide/formoterol prolonged EET 1 h post-morning dose versus formoterol by 69 s (P < 0.005) and placebo by 105 s... (More)
Background: Breathlessness and exercise intolerance frequently impact the daily life of patients with COPD. Methods: This double-blind, multicentre, three-period crossover study randomised 111 patients with COPD (mean age 64 years, mean FEV1 38% of predicted normal) to budesonide/formoterol 320/9 mu g, formoterol 9 mu g or placebo, twice daily for 1 week, following a 1-week run-in period with 1-week wash-out between treatments. Terbutaline (0.5 mg/dose) was used as needed. The primary efficacy variable was exercise endurance time (EET) at 75% peak work capacity with cycle ergometry assessed 1 h post-morning dose. Results: Budesonide/formoterol prolonged EET 1 h post-morning dose versus formoterol by 69 s (P < 0.005) and placebo by 105 s (P < 0.0001) and improved inspiratory capacity (IC) at isotime during exercise versus formoterol by 8% (P = 0.011) and placebo by 16% (P < 0.0001). Borg score at isotime was reduced by 0.48 (P = 0.12) and 0.78 (P = 0.014) compared with formoterol and placebo, respectively. At the repeated cycle test 6 h after morning dose, the effect on EET still favoured budesonide/formoterol over formoterol and placebo, while the isotime IC and Borg score were similar but better than placebo for the active study drugs. Budesonide/formoterol and formoterol improved health status (St George's Respiratory Questionnaire total score: mean difference versus placebo -2.4 and -2.2, respectively). All treatments were well tolerated. Conclusions: Budesonide/formoterol resulted in a significant improvement in endurance time 1 h after the last morning dose in a 1-week treatment period versus formoterol and placebo. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Budesonide/formoterol, COPD, Exercise tolerance
in
Respiratory Medicine
volume
104
issue
10
pages
1450 - 1459
publisher
Elsevier
external identifiers
  • wos:000282247300009
  • scopus:77956344161
ISSN
1532-3064
DOI
10.1016/j.rmed.2010.07.006
language
English
LU publication?
yes
id
3beba4dc-f1ce-4669-859b-952aebde93f2 (old id 1694081)
date added to LUP
2010-10-28 08:56:59
date last changed
2018-05-29 10:35:20
@article{3beba4dc-f1ce-4669-859b-952aebde93f2,
  abstract     = {Background: Breathlessness and exercise intolerance frequently impact the daily life of patients with COPD. Methods: This double-blind, multicentre, three-period crossover study randomised 111 patients with COPD (mean age 64 years, mean FEV1 38% of predicted normal) to budesonide/formoterol 320/9 mu g, formoterol 9 mu g or placebo, twice daily for 1 week, following a 1-week run-in period with 1-week wash-out between treatments. Terbutaline (0.5 mg/dose) was used as needed. The primary efficacy variable was exercise endurance time (EET) at 75% peak work capacity with cycle ergometry assessed 1 h post-morning dose. Results: Budesonide/formoterol prolonged EET 1 h post-morning dose versus formoterol by 69 s (P &lt; 0.005) and placebo by 105 s (P &lt; 0.0001) and improved inspiratory capacity (IC) at isotime during exercise versus formoterol by 8% (P = 0.011) and placebo by 16% (P &lt; 0.0001). Borg score at isotime was reduced by 0.48 (P = 0.12) and 0.78 (P = 0.014) compared with formoterol and placebo, respectively. At the repeated cycle test 6 h after morning dose, the effect on EET still favoured budesonide/formoterol over formoterol and placebo, while the isotime IC and Borg score were similar but better than placebo for the active study drugs. Budesonide/formoterol and formoterol improved health status (St George's Respiratory Questionnaire total score: mean difference versus placebo -2.4 and -2.2, respectively). All treatments were well tolerated. Conclusions: Budesonide/formoterol resulted in a significant improvement in endurance time 1 h after the last morning dose in a 1-week treatment period versus formoterol and placebo.},
  author       = {Worth, Heinrich and Forster, Karin and Eriksson, Göran and Nihlén, Ulf and Peterson, Stefan and Magnussen, Helgo},
  issn         = {1532-3064},
  keyword      = {Budesonide/formoterol,COPD,Exercise tolerance},
  language     = {eng},
  number       = {10},
  pages        = {1450--1459},
  publisher    = {Elsevier},
  series       = {Respiratory Medicine},
  title        = {Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD},
  url          = {http://dx.doi.org/10.1016/j.rmed.2010.07.006},
  volume       = {104},
  year         = {2010},
}