Elsevier

Respiratory Medicine

Volume 105, Issue 8, August 2011, Pages 1176-1188
Respiratory Medicine

Bronchodilator responsiveness and onset of effect with budesonide/formoterol pMDI in COPD

https://doi.org/10.1016/j.rmed.2011.02.020Get rights and content
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Summary

Background

Chronic obstructive pulmonary disease (COPD) patients are thought to have limited bronchodilator response, determined by changes in forced expiratory volume in 1 s (FEV1). In this study, we assessed bronchodilator response in patients with COPD using not only FEV1 but also changes in lung volume expressed as forced vital capacity (FVC) and inspiratory capacity (IC). We also evaluated the speed of onset of bronchodilation.

Methods

Data were from 2 randomized, double-blind, placebo-controlled studies (6-months [NCT00206154]; 12-months [NCT00206167]) in patients with moderate to very severe COPD. Treatments: twice daily budesonide/formoterol pressurized metered-dose inhaler (pMDI) 320/9 μg, budesonide/formoterol pMDI 160/9 μg, formoterol dry powder inhaler (DPI) 9 μg, placebo.

Results

The percentage of patients with FEV1 improvement (≥12% and ≥200 mL; American Thoracic Society [ATS] criterion) was 34–39% post-albuterol (screening). On day of randomization (DOR), a larger proportion receiving formoterol-containing treatment exhibited reversibility within 60 min: FEV1 (57–59%). Similar results were seen for IC (50–61%) and FVC (57–67%) using the same improvement criteria. The time to ≥15% FEV1 improvement on DOR was 5.0, 4.8, and 7.3 min for budesonide/formoterol 320/9, budesonide/formoterol 160/9, and formoterol, respectively. Time to ≥15% FEV1 improvement was better maintained with budesonide/formoterol than formoterol at treatment end (6 and 12 months).

Conclusions

Most patients with moderate to very severe COPD exhibit ATS-defined bronchodilator reversibility based on flow and lung volume measures after budesonide/formoterol pMDI or formoterol treatment. Budesonide/formoterol pMDI also has a rapid (within 5 min) onset of bronchodilation that is maintained over time compared with formoterol alone.

Keywords

Bronchodilation
Reversibility
Lung volume
COPD
Onset of effect
Treatment

Abbreviations

ATS
American Thoracic Society
BUD
budesonide
COPD
chronic obstructive pulmonary disease
DPI
dry powder inhaler
FEV1
forced expiratory volume in 1 s
FM
formoterol
FVC
forced vital capacity
IC
inspiratory capacity
ICS
inhaled corticosteroid
LABA
long-acting β2-adrenergic agonist
PBO
placebo
pMDI
pressurized metered-dose inhaler
TLC
total lung capacity
TORCH
Towards a Revolution in COPD Health
UPLIFT
Understanding Potential Long-Term Impacts on Function with Tiotropium trial

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