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OpenTrials
Completed

NCT Number: NCT03273933

DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices

Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control through innovative devices supporting usual care. In the first study arm, a new application (DragONE) for iOS and Android will be only used for patient monitoring. In the second study arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every 4 weeks for 12 weeks.

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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–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Palermo, 90146, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of moderate persistent asthma
  • Uncontrolled symptoms (C-ACT≤ 19)
  • Treated for at least 3 months
  • FEV1 between 60% and 90% of predicted value

Exclusion criteria

  • Symptoms of acute respiratory infection
  • Immunological or metabolic systemic disease
  • Major malformations of the upper airways
  • Active smoker

Treatment and study plan

DragONE

Device

The DragONE application for iOS and Android, developed in collaboration with the Institute for Educational Technologies of the National Research Council of Palermo, allow children to daily fill electronically the C-ACT questionnaire and the symptom diary card.

SmartOne

Device

A little portable spirometer connected to DragONE allows daily PEF monitoring.

Primary outcomes

  1. Acquisition and maintenance of the control status

    Time frame: Once every 4 weeks, for 12 weeks

    mean C-ACT score

Secondary outcomes

  1. Quality of life in asthma children

    Time frame: 12 weeks

    PAQLQ score

  2. Adherence to asthma treatment

    Time frame: 12 weeks

    MARS score

  3. Lung function: FEV1

    Time frame: 12 weeks

    Forced expiratory volume in the first second

  4. Lung function: FVC

    Time frame: 12 weeks

    Forced vital capacity

  5. Lung function: FEF 25-75

    Time frame: 12 weeks

    Forced expiratory flow at 25-75%

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Registry information

Acronym: DragONE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 6, 2017
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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