Asthma Clinical Trial
Official title:
The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
Verified date | June 2020 |
Source | Istituto per la Ricerca e l'Innovazione Biomedica |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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+.
Status | Completed |
Enrollment | 18 |
Est. completion date | January 23, 2020 |
Est. primary completion date | January 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility |
Inclusion Criteria: - uncontrolled mild or moderate persistent asthma; Exclusion Criteria: - acute upper respiratory infections; - immunological or metabolic systemic disease; - major malformations of the upper airways; - active smokers. |
Country | Name | City | State |
---|---|---|---|
Italy | Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council | Palermo | Sicily |
Lead Sponsor | Collaborator |
---|---|
Istituto per la Ricerca e l'Innovazione Biomedica |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medication Adherence Rating Scale (MARS) | Change in the MARS score from baseline to the end of treatment | 3 months | |
Secondary | Childhood Asthma Control Test (C-ACT) | Change in the C-ACT score from baseline to the end of treatment | 3 months | |
Secondary | Asthma Control Test (ACT) | Change in the ACT score from baseline to the end of treatment | 3 months | |
Secondary | Pediatric Asthma Quality of Life Questionnaire (PAQLQ) | Change in the PAQLQ score from baseline to the end of treatment | 3 months |
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