The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
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|ClinicalTrials.gov Identifier: NCT03788395|
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : September 26, 2019
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+.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Device: Symbicort Turbohaler plus Turbo+ Drug: Symbicort Turbohaler without Turbo+||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma|
|Actual Study Start Date :||January 10, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: Symbicort Turbohaler plus Turbo+
10 asthmatic children
Device: Symbicort Turbohaler plus Turbo+
Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.
Active Comparator: Symbicort Turbohaler without Turbo+
10 asthmatic children
Drug: Symbicort Turbohaler without Turbo+
Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.
- Medication Adherence Rating Scale (MARS) [ Time Frame: 3 months ]Change in the MARS score from baseline to the end of treatment
- Childhood Asthma Control Test (C-ACT) [ Time Frame: 3 months ]Change in the C-ACT score from baseline to the end of treatment
- Asthma Control Test (ACT) [ Time Frame: 3 months ]Change in the ACT score from baseline to the end of treatment
- Pediatric Asthma Quality of Life Questionnaire (PAQLQ) [ Time Frame: 3 months ]Change in the PAQLQ score from baseline to the end of treatment
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): NCT03788395
|Contact: Stefania La Grutta, PhDemail@example.com|
|Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council||Recruiting|
|Palermo, Sicily, Italy, 90146|
|Contact: Stefania La Grutta, PhD +390916809680 firstname.lastname@example.org|