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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 |
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| Control | Sham Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimized self-management of asthma | Other | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Age: 6-65 years old
Diagnosis of persistent asthma
Treatment level at study entry:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Gobbi, PhD | Contact | +390236593690 | a.gobbi@restech.it | |
| Pasquale Pio Pompilio, PhD | Contact | +390236593690 | p.pompilio@restech.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woolcock Institute of Medical Research | Not yet recruiting | Sydney | 2037 | Australia |
No Individual Participant Data (IPD) sharing planned at this stage
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Conventional self-management of asthma | Other | Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms |
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| 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 |
| Grenoble University Hospital | Recruiting | Grenoble | 38043 | France |
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| University Children's Hospital of Nancy | Recruiting | Nancy | 54500 | France |
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| Azienda Ospedaliero, Universitaria Meyer | Recruiting | Florence | FI | 50139 | Italy |
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| AOU Ospedali Riuniti Ancona | Recruiting | Ancona | 60126 | Italy |
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| ASST Papa Giovanni XXIII | Recruiting | Bergamo | 24127 | Italy |
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| Istituto di Farmacologia Traslazionale (IFT) del CNR | Not yet recruiting | Palermo | 90146 | Italy |
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| Istituto di Farmacologia Traslazionale (IFT) del CNR | Not yet recruiting | Palermo | 90146 | Italy |
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| Fondazione IRCCS Policlinico S. Matteo | Recruiting | Pavia | 27100 | Italy |
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| Azienda Unità Sanitaria Locale di Reggio Emilia | Recruiting | Reggio Emilia | 42124 | Italy |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |