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

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ClinicalTrials.gov Identifier: NCT03273933
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Stefania La Grutta, MD, Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

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.

Condition or disease Intervention/treatment Phase
Asthma Device: DragONE Device: SmartOne Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 10 children with DragONE only 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.

Experimental: 10 children with DragONE and SmartOne 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.

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




Primary Outcome Measures :
  1. Acquisition and maintenance of the control status [ Time Frame: Once every 4 weeks, for 12 weeks ]
    mean C-ACT score


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 12 weeks ]
    PAQLQ score

  2. Adherence to asthma treatment [ Time Frame: 12 weeks ]
    MARS score

  3. Lung function: FEV1 [ Time Frame: 12 weeks ]
    Forced expiratory volume in the first second

  4. Lung function: FVC [ Time Frame: 12 weeks ]
    Forced vital capacity

  5. Lung function: FEF 25-75 [ Time Frame: 12 weeks ]
    Forced expiratory flow at 25-75%



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273933


Contacts
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Contact: Stefania La Grutta, Ph.D. 0916809680 stefania.lagrutta@ibim.cnr.it
Contact: Giovanni Viegi, MD 0916809501 giovanni.viegi@ibim.cnr.it

Locations
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Italy
Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo Recruiting
Palermo, Italy, 90146
Contact: Stefania La Grutta, Ph.D.    +390916809680    stefania.lagrutta@ibim.cnr.it   
Contact: Giovanni Viegi, FERS    +390916809501    giovanni.viegi@ibim.cnr.it   
Sponsors and Collaborators
Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

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Responsible Party: Stefania La Grutta, MD, Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy., Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
ClinicalTrials.gov Identifier: NCT03273933     History of Changes
Other Study ID Numbers: 7/2017_B
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases