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Eformoterol n-of-1 trials in chronic obstructive pulmonary disease poorly reversible to salbutamol

Department of Medicine, University of Adelaide, Australia; Clinical Epidemiology and Health Outcomes Unit, The Queen Elizabeth Hospital, Australia; Respiratory Medicine, The Queen Elizabeth Hospital, Australia

S L Appleton

Department of Medicine, University of Adelaide, Australia

A J Veale

Respiratory Medicine, The Queen Elizabeth Hospital, Australia

H J McElroy

Department of Public Health, University of Adelaide, Australia

D Veljkovic

Pharmacy, The Queen Elizabeth Hospital, Australia

L Saccoia

Respiratory Medicine, The Queen Elizabeth Hospital, Australia

Aims: Benefits of long acting beta 2 agonists are unclear for severe chronic obstructive pulmonary disease (COPD) patients with poor response to short acting bronchodilators. We aimed to evaluate 1) effects of eformoterol in such patients using a ‘n-of-1’ double crossover study design, and 2) aggregate data as a double-blind, double crossover randomized control trial. Methods: Subjects with forced expiratory volume in one second (FEV₁) < 60% predicted, and poor response to short acting bronchodilators were studied six times over 18 weeks. During that time they were prescribed four weeks of either eformoterol or placebo, followed by the alternate, and then a second crossover. Four-weekly measures included six minute walk distance (6MWD), FEV₁, previous two weeks of symptoms, and chronic respiratory questionnaire (CRQ) including treatment goal items. Results: Of 27 original subjects (21 male, mean age of 70 years, five smokers, mean prebronchodilator FEV₁, 36% predicted), one subject had clinically significant concordant improvement in the CRQ dyspnoea domain and 6MWD (by 51 metres), but not for other outcomes. There were no concordant improvements in any other subjects. Aggregate double crossover data analysis demonstrated no improvement in any outcome measures. Conclusions: The ‘n-of-1’ study design and aggregate data analysis demonstrated lack of benefit from eformoterol in COPD patients with poor response to short acting bronchodilators.

Key Words: chronic obstructive pulmonary disease (COPD) • eformoterol

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