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

NCT03788395 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-06-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Istituto per la Ricerca e l'Innovazione Biomedica

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-10
Primary Completion
2020-01-23
Completion
2020-01-23

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03788395 on ClinicalTrials.gov