Modifications to an inhaler device to aid the interpretation of clinical trial data

George Bostock


Of the 200+ respiratory new chemical entities (NCE)s currently in clinical studies, a significant proportion are evaluated in clinical studies using the RPC Plastiape RS01 capsule dry powder inhaler (cDPI).  As with any drug delivery device, it is prone to use error and variability of dose.  This study demonstrates the benefits that can be obtained by instrumenting this type of device within the clinical setting.  By equipping the cDPI with a variety of commercial off-the-shelf (COTS) sensors, we are able to identify several critical patient behaviours within our laboratory test data, including failure to pierce the capsule, inhalation flowrate profile, orientation of inhaler throughout and confirmation of successful capsule emptying.  This enhanced-fidelity approach to inhaler instrumentation, where the device is designed for long-term in-home clinical studies (without needing any additional training or charging by the patient), represents a significant improvement in the level of usage data captured.  It is already clear that this quantified data could provide invaluable clarity on actual usage, potentially informing which data outliers could be discarded from drug efficacy studies, therefore improving the statistical power of the results.

Key Message

Clinical studies form a critical part of all drug development, and yet significant uncertainties remain due to patient use error.  For this study, an RS01 cDPI was instrumented with an array of the latest COTS sensors to enable the capture and analysis of a substantially enhanced range of user behaviours.  The results of our laboratory tests, coupled with the latest data fusion methods, highlighted a variety of major new usage insights, including whether or not the capsule was successfully pierced, whether it spun correctly and the overall capsule emptying performance.

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