Smart spacer supported medication adherence management in patients with asthma: study protocol for the randomized controlled OUTER SPACE trial

Aim: To assess overall feasibility of undertaking a definitive randomized controlled trial of a smart spacer device in adults with asthma treated in primary care with inhaled corticosteroids/long-acting beta agonists (+/-long-acting muscarinic antagonists) using a pressurized metered dose inhaler (pMDI). In particular, we aim to: 1) determine an estimated recruitment time for a RCT, 2) assess patient and healthcare provider satisfaction with the smart spacer, 3) explore the distribution of medication adherence patterns (persistence and inhaler technique) and clinical outcomes and 4) obtain data to calculate sample size for a definitive trial.Smart Spacer: The CE-marked smart spacer used in this study is based upon the Aerochamber Plus® with Flow Vu®. The smart spacer monitors both adherence and inhaler technique.Methods: Randomized controlled feasibility trial of 2 months. Patients will be recruited from 4 general practices in the Netherlands. Patients (n=40) will use the smart spacer for 1 month (t=-1). At t=0, they will be randomized into two groups. The intervention group will get tailored feedback and education on basis of data from the smart spacer, the control group will get usual care. After 1 month (t=1), the study ends and outcomes are assessed.Outcomes: At t=-1, t=0 and t=1, asthma control, WPAI, TAI and FeNO are measured. At t=0 and t=1, lung function will be tested. At t=1, usability is analyzed by the SUS questionnaire and structured interviews with patients and caregivers and a hair sample is taken.Discussion: Adherence to inhalation medicines is still a topic of major concern. This study will give insight in how a healthcare provider can objectively monitor patients’ adherence to inhalation medicines using a smart spacer. Furthermore we obtain end point data: what medication is when inhaled and is there sufficient technique. We will evaluate the potential of personalized smart spacer-data informed education. Declaration of Interest References and Clinical Trial Registry Information