NCT03788395

The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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+.

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	Symbicort Turbohaler plus Turbo+	Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.
DRUG	Symbicort Turbohaler without Turbo+	Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.

Timeline

• Start date: 2019-01-10
• Primary completion: 2020-01-23
• Completion: 2020-01-23
• First posted: 2018-12-27
• Last updated: 2020-06-09

Locations

1 site across 1 country: Italy