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

Summary 

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 μg, formoterol 9 μg 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 β₂-agonists on exercise tolerance in COPD patients.

www.clinicaltrials.gov registration number: NCT00489853.

Keywords: Budesonide/formoterol, COPD, Exercise tolerance