NCT04963140

Self-Management Of Asthma By Forced Oscillation Technique

Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Restech Srl · Industry
• Sex: All
• Age: 6 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Self-management strategies for asthma, including patients engagement and adherence to personalised action plans with advice on recognizing and responding to deterioration in control with effective treatments can improve asthma outcomes and possibly reduce the risk of future exacerbations. However, the real-life evidence is that asthma control remains sub-optimal in the majority of cases, thus increasing the related socio-economic costs worldwide. Because an increased variability of lung function remains a hallmark of poor asthma control and exacerbations, its assessment over time could contribute to the success of self-management plans. Previous studies have shown the potential of Forced Oscillation Technique (FOT) as a tool for monitoring increased variability of airway obstruction and for identifying the onset of acute deterioration of airway function. The aim of this study is to test the hypothesis that a personalised self-management plan including FOT improves asthma control and reduces number of days with increased symptoms compared to conventional asthma treatment.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Optimized self-management of asthma	Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) if an increased risk of asthma exacerbations is detected by the home monitoring device
OTHER	Conventional self-management of asthma	Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms

Timeline

• Start date: 2020-11-16
• Primary completion: 2024-04-01
• Completion: 2024-09-01
• First posted: 2021-07-15
• Last updated: 2023-02-13

Locations

10 sites across 3 countries: Australia, France, Italy