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

Asthma Clinical Trial

— DragONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273933
• Other study ID #: 7/2017_B
• Status: Completed
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: February 26, 2020

Study information

• Verified date: June 2020
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition and maintenance of the control status	mean C-ACT score	Once every 4 weeks, for 12 weeks
Secondary	Quality of life in asthma children	PAQLQ score	12 weeks
Secondary	Adherence to asthma treatment	MARS score	12 weeks
Secondary	Lung function: FEV1	Forced expiratory volume in the first second	12 weeks
Secondary	Lung function: FVC	Forced vital capacity	12 weeks
Secondary	Lung function: FEF 25-75	Forced expiratory flow at 25-75%	12 weeks