The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
Overview
- Phase
- Phase 4
- Intervention
- Symbicort Turbohaler plus Turbo+
- Conditions
- Asthma
- Sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Medication Adherence Rating Scale (MARS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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+.
Investigators
Stefania La Grutta, MD
Coordinator of the group "Clinical and Environmental Epidemiology of Pulmonary and Allergic Pediatric Diseases". Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Istituto per la Ricerca e l'Innovazione Biomedica
Eligibility Criteria
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.
Arms & Interventions
Symbicort Turbohaler plus Turbo+
10 asthmatic children
Intervention: Symbicort Turbohaler plus Turbo+
Symbicort Turbohaler without Turbo+
10 asthmatic children
Intervention: Symbicort Turbohaler without Turbo+
Outcomes
Primary Outcomes
Medication Adherence Rating Scale (MARS)
Time Frame: 3 months
Change in the MARS score from baseline to the end of treatment
Secondary Outcomes
- Childhood Asthma Control Test (C-ACT)(3 months)
- Asthma Control Test (ACT)(3 months)
- Pediatric Asthma Quality of Life Questionnaire (PAQLQ)(3 months)