A protocol for a randomised clinical trial of the effect of providing feedback on inhaler technique and adherence from an electronic device in patients with poorly controlled severe asthma

This paper describes the design of a prospective, randomized single-blind trial that will evaluate whether use of the INCA device leads to better clinical information and improved inhaler adherence versus current best practice in patients with severe uncontrolled asthma who have experienced at least one recent severe asthma exacerbation; target recruitment will be 220 patients. The primary endpoint will be the rate of adherence; secondary endpoints will include clinical outcomes, PEF, ACT score, AQLQ score, reliever use, and exacerbations. Participants will record PEF with a Vitalograph Asma-1 device, while inhaler use will be recorded using the INCA device, which was manufactured and supplied by Vitalograph.