Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD
(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:
https://lup.lub.lu.se/record/1694081
- author
- Worth, Heinrich ; Forster, Karin ; Eriksson, Göran LU ; Nihlén, Ulf LU ; Peterson, Stefan and Magnussen, Helgo
- organization
- publishing date
- 2010
- 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
- pmid:20692140
- 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
- 2016-04-01 14:55:56
- date last changed
- 2022-04-14 20:24:18
@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 < 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.}}, author = {{Worth, Heinrich and Forster, Karin and Eriksson, Göran and Nihlén, Ulf and Peterson, Stefan and Magnussen, Helgo}}, issn = {{1532-3064}}, keywords = {{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}}, doi = {{10.1016/j.rmed.2010.07.006}}, volume = {{104}}, year = {{2010}}, }