ABSTRACT

This case study is based on a Phase I double-blind trial to estimate the dose response of an active drug (D) using a surrogate endpoint, sGaw (specific conductance), in healthy volunteers using whole body plethysmography. sGaw represents airway conductance in the larger conducting airways and is considered to be a a useful surrogate for forced expiratory volume in one second (FEV1). It is hoped that if taken into further development the active drug will provide an effective treatment for patients suffering from chronic obstructive pulmonary disease (COPD) .