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OpenTrials
Completed

NCT Number: NCT03788395

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

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Palermo, Sicily, 90146, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symbicort Turbohaler plus Turbo+

Device

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

Symbicort Turbohaler without Turbo+

Drug

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

Primary outcomes

  1. Medication Adherence Rating Scale (MARS)

    Time frame: 3 months

    Change in the MARS score from baseline to the end of treatment

Secondary outcomes

  1. Childhood Asthma Control Test (C-ACT)

    Time frame: 3 months

    Change in the C-ACT score from baseline to the end of treatment

  2. Asthma Control Test (ACT)

    Time frame: 3 months

    Change in the ACT score from baseline to the end of treatment

  3. Pediatric Asthma Quality of Life Questionnaire (PAQLQ)

    Time frame: 3 months

    Change in the PAQLQ score from baseline to the end of treatment

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 27, 2018
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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