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Measuring bronchodilation in COPD clinical trials.

Z L Borrill1, C M Houghton, A A Woodcock

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

British Journal of Clinical Pharmacology
|April 2, 2005
PubMed
Summary
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Impulse oscillometry and plethysmography are more sensitive than spirometry for assessing bronchodilation in COPD clinical trials. These methods detect significant airway changes at lower salbutamol doses, improving trial efficiency.

Area of Science:

  • Pulmonary Medicine
  • Respiratory Physiology
  • Clinical Trial Methodology

Background:

  • Chronic Obstructive Pulmonary Disease (COPD) management relies on assessing bronchodilator response.
  • Accurate and sensitive measurement techniques are crucial for clinical trials evaluating COPD treatments.
  • Existing methods like spirometry may have limitations in detecting subtle bronchodilatory effects.

Purpose of the Study:

  • To compare the variability and sensitivity of impulse oscillometry, plethysmography, and spirometry.
  • To identify the most effective technique for measuring bronchodilation in COPD clinical trials.
  • To guide the selection of optimal pulmonary function tests for COPD research.

Main Methods:

  • Twenty-four COPD patients underwent repeated measurements of impulse oscillometry (R5, X5, RF), plethysmography (Raw, sGaw), and spirometry (FEV1, FVC, MMEF) to assess variability.

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  • Ascending doses of salbutamol (20-800 µg) were administered, with pulmonary function tests repeated after each dose.
  • Sensitivity was determined by identifying the lowest dose causing statistically significant changes exceeding intra-subject variability.

    • Main Results:

    • Impulse oscillometry (X5, RF) and plethysmography (sGaw) detected significant bronchodilation after 20 µg salbutamol.
    • Impulse oscillometry (R5) and plethysmography (Raw) showed significant effects after 50 µg.
    • Spirometry (FEV1) was less sensitive, requiring 100 µg to detect significant bronchodilation.

    Conclusions:

    • Impulse oscillometry and plethysmography are more sensitive than spirometry for assessing bronchodilation in COPD.
    • These techniques should be preferred for measuring bronchodilator response in COPD clinical trials.
    • The findings support the use of oscillometry and plethysmography for enhanced detection of treatment effects in COPD research.