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

June 5, 2020 updated by: Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica

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+.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Sicily
      • Palermo, Sicily, Italy, 90146
        • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symbicort Turbohaler plus Turbo+
10 asthmatic children
Device: Symbicort Turbohaler plus Turbo+
Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.
Active Comparator: Symbicort Turbohaler without Turbo+
10 asthmatic children
Drug: Symbicort Turbohaler without Turbo+
Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence Rating Scale (MARS)
Time Frame: 3 months
Change in the MARS score from baseline to the end of treatment
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childhood Asthma Control Test (C-ACT)
Time Frame: 3 months
Change in the C-ACT score from baseline to the end of treatment
3 months
Asthma Control Test (ACT)
Time Frame: 3 months
Change in the ACT score from baseline to the end of treatment
3 months
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Time Frame: 3 months
Change in the PAQLQ score from baseline to the end of treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

December 21, 2018

First Submitted That Met QC Criteria

December 26, 2018

First Posted (Actual)

December 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 5, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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