Asthma
Conditions
Brief 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.
Interventions
OTHEROptimized 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
OTHERConventional 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
Sponsors
Restech Srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control | 6 months from enrolment | Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) |
| Symptoms | From month no. 2 through study completion, an average of 7 months | Change of percentage of days with non-increased symptoms from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control | 3 months from enrolment | Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) |
| Exacerbation | Through study completion, an average of 9 months | Change of number of moderate and severe exacerbations |
| Controller medication usage | From month no. 2 through study completion, an average of 7 months | Change of days with increased controller (inhaled corticosteroid (ICS) alone or in combination with long-acting bronchodilator (LABA)) |
| Absence days from school/work | Through study completion, an average of 9 months | Change of absence days from work/school due to asthma |
| Day-to-day variability of respiratory resistance | Through study completion, an average of 9 months | Change of average day-to-day coefficient of variation of inspiratory resistance (CVRinsp) |
| Accuracy of CVRinsp in detecting exacerbations | Through study completion, an average of 9 months | 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 |
Countries
Australia, France, Italy
Outcome results
None listed