Validation of a metered dose inhaler electronic monitoring device: implications for asthma clinical trial use

Abstract

BackgroundThe SmartTouch Ventolin monitor (Adherium, Auckland, New Zealand) is an electronic monitor for use with a Ventolin metered dose inhaler, which records the date and time of inhaler actuations. This technology has the potential to allow in-depth analysis of patterns of inhaler use in clinical trial settings. The aim of this study was to determine the accuracy of the SmartTouch Ventolin monitor in recording Ventolin actuations.Methods20 SmartTouch Ventolin monitors were attached to Ventolin metered dose inhalers. Bench testing was performed over a 10-week period, to reflect the potential time frame between visits in a clinical trial. Inhaler actuations were recorded in a paper diary, which was compared with data uploaded from the monitors.Results2560 actuations were performed during the 10-week study period. Monitor sensitivity for diary-recorded actuations was 99.9% with a lower 97.5% confidence bound of 99.7%. The positive predictive value for diary-recorded actuations was 100% with a 97.5% lower confidence bound of 99.9%.ConclusionsThe SmartTouch Ventolin monitor is highly accurate in recording and retaining electronic data. It can be recommended for use in clinical trial settings in which training and quality control systems are incorporated into study protocols to ensure accurate data acquisition.

Diagnosis and Management of Severe Asthma

“…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.…”

Design and Development of a Non-volatile Counter for Metered Dose Inhaler (MDI)

“…The third type of the MDI electronic counter is called SmartTouch Ventolin [21]. This kind of MDI electronic is able to record the date and time, and the actuation number.…”

“…PuffMinder Doser [20] Display the available puff of salbutamol on the liquid crystal display (LCD). SmartTouch Ventolin monitor [21] Record the date and time an inhaler is inserted or removed from its case. MDI mechanical counter [23] Using mechanical concept to count the available puff in the MDI canister and display with 3-digit meter.…”

Effective deployment of technology-supported management of chronic respiratory conditions: a call for stakeholder engagement

“…As with mobile apps, connected devices often secure initial engagement but their long-term clinical benefit is less clear. Although devices such as smart inhalers provide accurate data, 33 they have not yet been studied as part of a holistic behavioral change system. Small studies of the isolated introduction of smart inhalers have not shown an increase in medication adherence or symptom improvement.…”