Three-month validation of a turbuhaler electronic monitoring device: implications for asthma clinical trial use

Abstract

BackgroundElectronic monitoring of inhaled asthma therapy is suggested as the ‘gold standard’ for measuring patterns of medication use in clinical trials. The SmartTurbo (Adherium (NZ) Ltd, Auckland, New Zealand) is an electronic monitor for use with a turbuhaler device (AstraZeneca, UK). The aim of this study was to determine the accuracy of the SmartTurbo in recording Symbicort actuations over a 12-week period of use.MethodsTwenty SmartTurbo monitors were attached to the base of 20 Symbicort turbuhalers. Bench testing in a research facility was undertaken on days 0, 5, 6, 7, 8, 9, 14, 21, 28, 56 and 84. Patterns of ‘low-use’ (2 sets of 2 actuations on the same day) and ‘high-use’ (2 sets of 8 actuations on the same day) were performed. The date and time of actuations were recorded in a paper diary and compared with data uploaded from the SmartTurbo monitors.Results2800 actuations were performed. Monitor sensitivity was 99.9% with a lower 97.5% confidence bound of 99.6%. The positive predictive value was 99.9% with a 97.5% lower confidence bound of 99.7%. Accuracy was not affected by whether the pattern of inhaler use was low or high, or whether there was a delay in uploading the actuation data.ConclusionsThe SmartTurbo monitor is highly accurate in recording and retaining electronic data in this 12-week bench study. It can be recommended for use in clinical trial settings, in which quality control systems are incorporated into study protocols to ensure accurate data acquisition.

The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given ‘as needed’ in mild asthma: study protocols for two randomised controlled trials

“…The TUM is a validated electronic data logger designed to be attached to a Turbuhaler® [18, 22]. The TUM contains an electronic clock that logs the date and time when the Turbuhaler® base grip is rotated back and forth.…”

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“…The emerging field of low-cost sensors and data transmission has led to a surge in devices attached to or embedded in inhalers intended to address this problem by detecting inhaler technique and assessing adherence. The term smart inhaler covers a range of technology from simple tracking devices which record when an inhaler was used [4][5][6], to those which remind patients to take their inhaler [7,8], offer feedback on technique and timing, or record the interaction of environment and individual that prompts inhaler use. Other devices have sensors incorporating advanced signal-processing to analyze inspiratory flow rates, and characterize inhaler technique [9].…”

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“…A test based on the suppression of fractional exhaled nitric oxide (FeNO) levels has been used to identify nonadherence to ICS in a difficult asthma population, 24 but electronic counters that can be attached or built within an inhaler represent a direct and less obtrusive method of assessing adherence. 25,26 With these electronic devices, it is possible to monitor whether any improvement in adherence to inhaled therapies can lead to an improvement in asthma control. Alternatively, in some patients, their nonadherence may have been engendered by a true lack of effect of these drugs in controlling asthma in a severe therapyresistant asthma patient.…”