Self-Management Of Asthma By Forced Oscillation Technique

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Other: Optimized self-management of asthma
* Other: Conventional self-management of asthma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 6-65 years old Diagnosis of persistent asthma Treatment level at study entry: For children 6-11 years: Step2 or Step3 of the GINA document For adolescents and adults 12-65 years: Step2 under daily low-dose inhaled corticosteroids (ICS), Step 3 or Step 4 of the GINA document Uncontrolled asthma (ACQ-5 > 1.5) that, according to the physician, does not warrant an immediate step-up of the treatment History of moderate or severe exacerbations in the twelve (12) months prior to baseline visit Exclusion Criteria: Use of oral, rectal or parenteral glucocorticosteroids 30 days before enrolment Treatment with leukotriene receptor antagonist (LTRA) Treatment with maintenance and reliever therapy (SMART/MART) Smoking, current or previous with a history of 10 pack-years or more Documented COPD or other concomitant clinically important diseases or cognitive impairment that, according to the physician, may interfere with the subject's ability or safety to participate in the study Obesity (for subjects 6-19 years: BMI ≥ 95th percentile; for adults 20-65 years: BMI ≥ 40kg⋅m-2 For school-age children (6-11 years old): gestational age at birth < 37 weeks or documented bronchopulmonary dysplasia (BPD) Prolonged absence from home during the monitoring period (i.e. at recruitment, expected ≥3 consecutive weeks for ≥2 times during the 9- month monitoring period) Subject currently enrolled in other clinical trials related or involving the study of the respiratory system History of near-fatal asthma Women who are pregnant, nursing or intending to become pregnant during the time of the study Absence of health insurance coverage (applies to French centres only)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention subjects will monitor their lung function daily by Forced Oscillation Technique (FOT) device. The embedded algorithm signals when an increased risk of exacerbation is detected and subjects shall modify their treatment based on the action plan prescribed by the study doctor at enrolment and used for the self-management of their asthma | Other: Optimized self-management of asthma<br>* 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<br>|
| Sham Comparator: Control<br>Control subjects will monitor their lung function daily by Forced Oscillation Technique (FOT) device. The embedded algorithm used in the intervention arm is disabled. Subjects will follow the action plan prescribed by the study doctor at enrolment for the self-management of their asthma | Other: Conventional self-management of asthma<br>* Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control | Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) | 6 months from enrolment | 
| Symptoms | Change of percentage of days with non-increased symptoms from baseline | From month no. 2 through study completion, an average of 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control | Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) | 3 months from enrolment | 
| Asthma Control | Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) | 9 months from enrolment | 
| Asthma Control | Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma | 3 months from enrolment | 
| Asthma Control | Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma | 6 months from enrolment | 
| Asthma Control | Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma | 9 months from enrolment | 
| Asthma Control | Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5) | 3 months from enrolment | 
| Asthma Control | Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5) | 6 months from enrolment | 
| Asthma Control | Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5) | 9 months from enrolment | 
| Asthma Control | Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome | 3 months from enrolment | 
| Asthma Control | Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome | 6 months from enrolment | 
| Asthma Control | Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome | 9 months from enrolment | 
| Exacerbation | Change of number of moderate and severe exacerbations | Through study completion, an average of 9 months | 
| Controller medication usage | Change of days with increased controller (inhaled corticosteroid (ICS) alone or in combination with long-acting bronchodilator (LABA)) | From month no. 2 through study completion, an average of 7 months | 
| Absence days from school/work | Change of absence days from work/school due to asthma | Through study completion, an average of 9 months | 
| Day-to-day variability of respiratory resistance | Change of average day-to-day coefficient of variation of inspiratory resistance (CVRinsp) | Through study completion, an average of 9 months | 
| Accuracy of CVRinsp in detecting exacerbations | In the control arm of the study only: accuracy, sensitivity and specificity of day-to-day variability of FOT parameters and of related prediction algorithm in identifying the occurrence of future moderate and severe exacerbations | Through study completion, an average of 9 months |