The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
1 other identifier
interventional
18
1 country
1
Brief Summary
The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age. In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca" developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application. The present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started Jan 2019
Shorter than P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2018
CompletedFirst Posted
Study publicly available on registry
December 27, 2018
CompletedStudy Start
First participant enrolled
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2020
CompletedJune 9, 2020
June 1, 2020
1 year
December 21, 2018
June 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Medication Adherence Rating Scale (MARS)
Change in the MARS score from baseline to the end of treatment
3 months
Secondary Outcomes (3)
Childhood Asthma Control Test (C-ACT)
3 months
Asthma Control Test (ACT)
3 months
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
3 months
Study Arms (2)
Symbicort Turbohaler plus Turbo+
EXPERIMENTAL10 asthmatic children
Symbicort Turbohaler without Turbo+
ACTIVE COMPARATOR10 asthmatic children
Interventions
Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.
Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.
Eligibility Criteria
You may qualify if:
- \- uncontrolled mild or moderate persistent asthma;
You may not qualify if:
- acute upper respiratory infections;
- immunological or metabolic systemic disease;
- major malformations of the upper airways;
- active smokers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, 90146, Italy
Related Publications (1)
Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
PMID: 35691614DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Coordinator of the group "Clinical and Environmental Epidemiology of Pulmonary and Allergic Pediatric Diseases". Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Study Record Dates
First Submitted
December 21, 2018
First Posted
December 27, 2018
Study Start
January 10, 2019
Primary Completion
January 23, 2020
Study Completion
January 23, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06