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The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age.
In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca" developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application.
The present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbicort Turbohaler plus Turbo+ | Experimental | 10 asthmatic children |
|
| Symbicort Turbohaler without Turbo+ | Active Comparator | 10 asthmatic children |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort Turbohaler plus Turbo+ | Device | Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence Rating Scale (MARS) | Change in the MARS score from baseline to the end of treatment | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Childhood Asthma Control Test (C-ACT) | Change in the C-ACT score from baseline to the end of treatment | 3 months |
| Asthma Control Test (ACT) | Change in the ACT score from baseline to the end of treatment |
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Inclusion Criteria:
- uncontrolled mild or moderate persistent asthma;
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council | Palermo | Sicily | 90146 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35691614 | Derived | Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2. |
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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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| Symbicort Turbohaler without Turbo+ | Drug | Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months. |
|
| 3 months |
| Pediatric Asthma Quality of Life Questionnaire (PAQLQ) | Change in the PAQLQ score from baseline to the end of treatment | 3 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |