Status:

COMPLETED

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

Lead Sponsor:

Istituto per la Ricerca e l'Innovazione Biomedica

Conditions:

Asthma

Eligibility:

All Genders

6-11 years

Phase:

NA

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 i...

Eligibility Criteria

Inclusion

  • 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

  • Symptoms of acute respiratory infection
  • Immunological or metabolic systemic disease
  • Major malformations of the upper airways
  • Active smoker

Key Trial Info

Start Date :

March 8 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 26 2020

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT03273933

Start Date

March 8 2018

End Date

February 26 2020

Last Update

June 9 2020

Active Locations (1)

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1

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

Palermo, Italy, 90146