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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 26, 2020

Interventions

  • Device: DragONE
    • 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.
  • Device: SmartOne
    • A little portable spirometer connected to DragONE allows daily PEF monitoring.

Arms, Groups and Cohorts

  • Active Comparator: 10 children with DragONE only
  • Experimental: 10 children with DragONE and SmartOne

Clinical Trial Outcome Measures

Primary Measures

  • Acquisition and maintenance of the control status
    • Time Frame: Once every 4 weeks, for 12 weeks
    • mean C-ACT score

Secondary Measures

  • Quality of life in asthma children
    • Time Frame: 12 weeks
    • PAQLQ score
  • Adherence to asthma treatment
    • Time Frame: 12 weeks
    • MARS score
  • Lung function: FEV1
    • Time Frame: 12 weeks
    • Forced expiratory volume in the first second
  • Lung function: FVC
    • Time Frame: 12 weeks
    • Forced vital capacity
  • Lung function: FEF 25-75
    • Time Frame: 12 weeks
    • Forced expiratory flow at 25-75%

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istituto per la Ricerca e l’Innovazione Biomedica
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stefania La Grutta, MD, Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy. – Istituto per la Ricerca e l’Innovazione Biomedica

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.