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Br J Clin Pharmacol. 2005 Apr;59(4):379-84.

Measuring bronchodilation in COPD clinical trials.

Author information

1
Medicines Evaluation Unit, North-west Lung Centre, Wythenshawe Hospital, Manchester, UK. zborrill@meu.org.uk

Abstract

AIMS:

The aim of this study was to compare the variability and sensitivity of impulse oscillometry (R5, X5 and RF), plethysmography (Raw and sGaw) and spirometry (FEV1, FVC and MMEF) in order to determine the most powerful technique for assessing bronchodilation in COPD clinical trials.

METHODS:

Twenty-four patients with COPD had impulse oscillometry, plethysmography and spirometry measured twice 30 mins apart, to determine variability. Then ascending doses of salbutamol (20, 50, 100, 200, 400 and 800 microg) were given and the same measurements made after each dose. Significant changes greater than variability were determined for each performed measurement (expressed as mean percentage improvement with 95% CI).

RESULTS:

Significant effects (P < 0.05) were detected after 20 microg by X5 (18.5% CI 9.8-27.2) RF (11.1% CI 7.2-15.0) and sGaw (21.5% CI 10.1-32.9), and after 50 microg by R5 (16.7% CI 10.8-22.5) and Raw (19.7% CI 13.0-26.4). FEV1 was less sensitive, detecting significant bronchodilation at 100 microg (10.2% CI 7.4-12.9).

CONCLUSIONS:

We conclude that impulse oscillometry and plethysmography should be considered the preferred techniques for measuring bronchodilation in COPD clinical trials.

PMID:
15801931
PMCID:
PMC1884799
DOI:
10.1111/j.1365-2125.2004.02261.x
[Indexed for MEDLINE]
Free PMC Article

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