Improving Adherence by Guiding Inhalation via Electronic monitoring in children

Rationale: It has been shown that therapy adherence is suboptimal in children with asthma limiting the effect of inhaled medication. In this study, the effect of providing qualitative feedback on therapy adherence and inhalation technique is assessed.

Objective: The primary objective of this study is to improve asthma control in children with uncontrolled asthma by trying to improve their therapy adherence and inhalation technique through feedback.

Study design: The first phase consists of a 4 week observational study period, where the therapy adherence and inhalation technique of the patients is assessed. Parameters related to poor adherence are determined in this phase. The second phase lasting 6 weeks consists of a randomised controlled trial where one group receives immediate smart feedback on therapy adherence and inhalation technique and the other group does not receive feedback. Finally, in phase 3, the lasting effect of qualitative feedback will be assessed. This phase can be seen as a follow-up and patients will receive treatment depending on asthma control and therapy adherence & inhalation technique according to standard care and GINA recommendations. The options consist of: no change in medication, step-up therapy, step-down therapy or consultation with the paediatrician. Feedback will be ceased for all subjects during phase 3.

Study population: The study population consists of children with uncontrolled asthma in the range of 6 until 18 years of age. The randomisation process will be stratified for age with a cut-off at 12 years old and use of nasal corticosteroids.

Intervention: For this study, a RespiroTM add-on device is attached to the current inhaler therapy to measure critical parameters such as date and time of inhalation, peak flow, duration of the inhalation. Non-critical parameters as orientation of the inhaler, and opening and closing the inhaler will also be assessed.

Main study parameters/endpoints: The main study parameter is clinical improvement in patients with uncontrolled asthma. Clinical improvement is assessed by FEV1, lung function variability and the (c-)ACT score.

It is expected that providing children with active qualitative feedback on performed inhalations will directly improve therapy adherence and inhalation technique and therefore will increase asthma control in both short and long term.

The study is seperated in 3 phases. Phase 1 lasts 4 weeks and phases 2 and 3 both last 6 weeks. Lung function will be assessed at the end of each phase in MST by spirometry and a(n) (c-)ACT questionnaire. An interim analysis will be performed after halfway through the inclusion at the end of phase 2 to assess the true effect of the qualitative feedback.

Providing feedback over inhalation technique and therapy adherence by an add-on device provided by AMIKO