search
Back to results

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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
DragONE
SmartOne
Sponsored by
Istituto per la Ricerca e l'Innovazione Biomedica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

10 children with DragONE only

10 children with DragONE and SmartOne

Arm Description

Outcomes

Primary Outcome Measures

Acquisition and maintenance of the control status
mean C-ACT score

Secondary Outcome Measures

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

Full Information

First Posted
September 5, 2017
Last Updated
June 5, 2020
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
search

1. Study Identification

Unique Protocol Identification Number
NCT03273933
Brief Title
DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices
Acronym
DragONE
Official Title
DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 children with DragONE only
Arm Type
Active Comparator
Arm Title
10 children with DragONE and SmartOne
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
DragONE
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SmartOne
Intervention Description
A little portable spirometer connected to DragONE allows daily PEF monitoring.
Primary Outcome Measure Information:
Title
Acquisition and maintenance of the control status
Description
mean C-ACT score
Time Frame
Once every 4 weeks, for 12 weeks
Secondary Outcome Measure Information:
Title
Quality of life in asthma children
Description
PAQLQ score
Time Frame
12 weeks
Title
Adherence to asthma treatment
Description
MARS score
Time Frame
12 weeks
Title
Lung function: FEV1
Description
Forced expiratory volume in the first second
Time Frame
12 weeks
Title
Lung function: FVC
Description
Forced vital capacity
Time Frame
12 weeks
Title
Lung function: FEF 25-75
Description
Forced expiratory flow at 25-75%
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo
City
Palermo
ZIP/Postal Code
90146
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs