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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03273933

Acronym

DragONE

Enrollment

Registered

2017-09-06

Start date

2018-03-08

Completion date

2020-02-26

Last updated

2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DEVICEDragONE

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.

DEVICESmartOne

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 11 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Acquisition and maintenance of the control status	Once every 4 weeks, for 12 weeks	mean C-ACT score

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026