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

BMJ Open Resp Res 2016;3:e000128 doi:10.1136/bmjresp-2016-000128

• Respiratory research

1. Janine Pilcher1,2, 
2. Mark Holliday2, 
3. Stefan Ebmeier2, 
4. Steve McKinstry2, 
5. Fatiha Messaoudi2,
6. Mark Weatherall1,3 and 
7. Richard Beasley1,2

+Author Affiliations

1. ¹Capital and Coast District Health Board, Wellington, New Zealand
2. ²Medical Research Institute of New Zealand, Wellington, New Zealand
3. ³Wellington School of Medicine & Health Sciences, University of Otago Wellington, Wellington, New Zealand

1. Correspondence toDr Stefan Ebmeier; stefan.ebmeier@mrinz.ac.nz

Abstract

Background The 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.

Methods 20 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.

Results 2560 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%.

Conclusions The 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.