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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788395
• Other study ID #: 10/2018
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2019
• Est. completion date: January 23, 2020

Study information

• Verified date: June 2020
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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+.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council	Palermo	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence Rating Scale (MARS)	Change in the MARS score from baseline to the end of treatment	3 months
Secondary	Childhood Asthma Control Test (C-ACT)	Change in the C-ACT score from baseline to the end of treatment	3 months
Secondary	Asthma Control Test (ACT)	Change in the ACT score from baseline to the end of treatment	3 months
Secondary	Pediatric Asthma Quality of Life Questionnaire (PAQLQ)	Change in the PAQLQ score from baseline to the end of treatment	3 months