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

Istituto per la Ricerca e l'Innovazione Biomedica

Status: Completed

Conditions: Asthma

Treatments: Device: SmartOne; Device: DragONE

Study type: Interventional

Funder types: Other

Identifiers

NCT03273933

7/2017_B

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

10 children with DragONE only

Active Comparator group

Treatment:

Device: DragONE

10 children with DragONE and SmartOne

Experimental group

Treatment:

Device: DragONE

Device: SmartOne