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

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 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. www.clinicaltrials.gov registration number: NCT00489853.

journal_name

Respir Med

journal_title

Respiratory medicine

authors

Worth H,Förster K,Eriksson G,Nihlén U,Peterson S,Magnussen H

doi

10.1016/j.rmed.2010.07.006

subject

Has Abstract

pub_date

2010-10-01 00:00:00

pages

1450-9

issue

eissn

0954-6111

issn

1532-3064

pii

S0954-6111(10)00325-2

journal_volume

104

pub_type

杂志文章,多中心研究,随机对照试验

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