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Tomographic Airway Imaging and Clinical Biomarkers of Drug Effect: Enhancing Traditional Spirometry

De Backer J.

RDD Europe 2011. Volume 1, 2011: 189-196.

Abstract:

Forced expiratory volume in one second (FEV1) is considered the gold standard to describe the function of the respiratory system. The insensitive nature of FEV1, however, has in the past resulted in drug development and registration challenges. Imaging and, in particular, high-resolution computed tomography (HRCT) may complement the existing lung function tests to provide additional regional information relating to airway structure. Tools such as airway and lung segmentation and flow simulations have been demonstrated to provide significant benefits over traditional lung function testing. Clinical trials have demonstrated that CFD calculations based on airway geometries of asthmatic patients provide additional information about changes in regional airway resistance. Changes in airway resistance correlated with observed changes in spirometric values confirming the validity of the imaging methods. Further clinical studies, which include imaging, to assess the effects of new inhalation therapies, should be performed to establish the value of this method in the development cycle of respiratory drugs.