Self-Management Of Asthma By Forced Oscillation Technique
- Conditions
- Asthma
- Interventions
- Other: Optimized self-management of asthmaOther: Conventional self-management of asthma
- Registration Number
- NCT04963140
- Lead Sponsor
- Restech Srl
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
-
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Optimized self-management of asthma 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 Control Conventional self-management of asthma 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
- Primary Outcome Measures
Name Time Method Symptoms From month no. 2 through study completion, an average of 7 months Change of percentage of days with non-increased symptoms from baseline
Asthma Control 6 months from enrolment Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
- Secondary Outcome Measures
Name Time Method 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
Absence days from school/work Through study completion, an average of 9 months Change of absence days from work/school due to asthma
Exacerbation Through study completion, an average of 9 months Change of number of moderate and severe exacerbations
Asthma Control 9 months from enrolment Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome
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))
Trial Locations
- Locations (9)
Fondazione IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Istituto di Farmacologia Traslazionale (IFT) del CNR
🇮🇹Palermo, Italy
Woolcock Institute of Medical Research
🇦🇺Sydney, Australia
Grenoble University Hospital
🇫🇷Grenoble, France
Azienda Unità Sanitaria Locale di Reggio Emilia
🇮🇹Reggio Emilia, Italy
University Children's Hospital of Nancy
🇫🇷Nancy, France
AOU Ospedali Riuniti Ancona
🇮🇹Ancona, Italy
Azienda Ospedaliero, Universitaria Meyer
🇮🇹Firenze, FI, Italy