Asthma
Conditions
Brief summary
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+.
Interventions
DEVICESymbicort Turbohaler plus Turbo+
Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.
DRUGSymbicort Turbohaler without Turbo+
Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.
Sponsors
Istituto per la Ricerca e l'Innovazione Biomedica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
\- uncontrolled mild or moderate persistent asthma;
Exclusion criteria
* acute upper respiratory infections; * immunological or metabolic systemic disease; * major malformations of the upper airways; * active smokers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Rating Scale (MARS) | 3 months | Change in the MARS score from baseline to the end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Childhood Asthma Control Test (C-ACT) | 3 months | Change in the C-ACT score from baseline to the end of treatment |
| Asthma Control Test (ACT) | 3 months | Change in the ACT score from baseline to the end of treatment |
| Pediatric Asthma Quality of Life Questionnaire (PAQLQ) | 3 months | Change in the PAQLQ score from baseline to the end of treatment |
Countries
Italy
Outcome results
None listed