Document Detail

Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD.
MedLine Citation:
PMID:  20692140     Owner:  NLM     Status:  MEDLINE    
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 FEV(1) 38% of predicted normal) to budesonide/formoterol 320/9 microg, formoterol 9 microg 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. This study demonstrates, for the first time, the benefit of inhaled corticosteroids in addition to long-acting beta(2)-agonists on exercise tolerance in COPD patients. registration number: NCT00489853.
Heinrich Worth; Karin Förster; Göran Eriksson; Ulf Nihlén; Stefan Peterson; Helgo Magnussen
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-08-07
Journal Detail:
Title:  Respiratory medicine     Volume:  104     ISSN:  1532-3064     ISO Abbreviation:  Respir Med     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-09-06     Completed Date:  2011-02-24     Revised Date:  2013-06-11    
Medline Journal Info:
Nlm Unique ID:  8908438     Medline TA:  Respir Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  1450-9     Citation Subset:  IM    
Medical Department I, Fürth Hospital, Fürth, Germany.
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MeSH Terms
Administration, Inhalation
Aged, 80 and over
Bronchodilator Agents / administration & dosage*
Budesonide / administration & dosage*
Cross-Over Studies
Double-Blind Method
Drug Therapy, Combination / methods
Dyspnea / drug therapy*,  physiopathology
Ethanolamines / administration & dosage*
Exercise Test
Exercise Tolerance / drug effects*,  physiology
Forced Expiratory Volume / drug effects,  physiology
Middle Aged
Pulmonary Disease, Chronic Obstructive / drug therapy*,  physiopathology
Treatment Outcome
Reg. No./Substance:
0/Bronchodilator Agents; 0/Ethanolamines; 51333-22-3/Budesonide; 5ZZ84GCW8B/formoterol

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