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

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) aggreg...

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Bibliographic Details
Published in:Chronic respiratory disease 2004, Vol.1 (2), p.63-69
Main Authors: Smith, B J, Appleton, S L, Veale, A J, McElroy, H J, Veljkovic, D, Saccoia, L
Format: Article
Language:English
Subjects:
Adrenergic beta-Agonists - therapeutic use
Aged, 80 and over
Albuterol - therapeutic use
Autacoids
Bronchodilator Agents - therapeutic use
Cross-Over Studies
Drug Resistance
Ethanolamines - therapeutic use
Female
Forced Expiratory Volume
Formoterol Fumarate
Humans
Male
Pulmonary Disease, Chronic Obstructive - drug therapy
Surveys and Questionnaires
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Summary: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.
ISSN:1479-9731
1479-9723
1479-9731
DOI:10.1191/1479972304cd028oa