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

Istituto per la Ricerca e l'Innovazione Biomedica

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Device: Symbicort Turbohaler plus Turbo+; Drug: Symbicort Turbohaler without Turbo+

Study type: Interventional

Funder types: Other

Identifiers

NCT03788395

10/2018

Details and patient eligibility

About

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+.

Enrollment: 18 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Symbicort Turbohaler plus Turbo+

Experimental group

Description:

10 asthmatic children

Treatment:

Device: Symbicort Turbohaler plus Turbo+

Symbicort Turbohaler without Turbo+

Active Comparator group

Description:

10 asthmatic children

Treatment:

Drug: Symbicort Turbohaler without Turbo+