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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2020-01-23

Brief Summary

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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+.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Symbicort Turbohaler plus Turbo+

10 asthmatic children

Group Type EXPERIMENTAL

Symbicort Turbohaler plus Turbo+

Intervention Type DEVICE

Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.

Symbicort Turbohaler without Turbo+

10 asthmatic children

Group Type ACTIVE_COMPARATOR

Symbicort Turbohaler without Turbo+

Intervention Type DRUG

Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.

Interventions

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Symbicort Turbohaler plus Turbo+

Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.

Intervention Type DEVICE

Symbicort Turbohaler without Turbo+

Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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.

Responsibility Role PRINCIPAL_INVESTIGATOR