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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Device: Symbicort Turbohaler plus Turbo+; Drug: Symbicort Turbohaler without Turbo+

• Registration Number: NCT03788395
• Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

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+.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-27
• Study Start: 2019-01-10
• Primary Completion: 2020-01-23
• Study Completion: 2020-01-23
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symbicort Turbohaler plus Turbo+	Symbicort Turbohaler plus Turbo+	10 asthmatic children
Symbicort Turbohaler without Turbo+	Symbicort Turbohaler without Turbo+	10 asthmatic children

Primary Outcome Measures

Name	Time	Method
Medication Adherence Rating Scale (MARS)	3 months	Change in the MARS score from baseline to the end of treatment

Secondary Outcome Measures

Name	Time	Method
Childhood Asthma Control Test (C-ACT)	3 months	Change in the C-ACT score from baseline to the end of treatment
Asthma Control Test (ACT)	3 months	Change in the ACT score from baseline to the end of treatment
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)	3 months	Change in the PAQLQ score from baseline to the end of treatment

Trial Locations

Locations (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council; 🇮🇹 Palermo, Sicily, Italy