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The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788395
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica

Study Description
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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+.


Condition or disease Intervention/treatment Phase
Asthma Device: Symbicort Turbohaler plus Turbo+ Drug: Symbicort Turbohaler without Turbo+ Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
Actual Study Start Date : January 10, 2019
Actual Primary Completion Date : January 23, 2020
Actual Study Completion Date : January 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Medication Adherence Rating Scale (MARS) [ Time Frame: 3 months ]
    Change in the MARS score from baseline to the end of treatment


Secondary Outcome Measures :
  1. Childhood Asthma Control Test (C-ACT) [ Time Frame: 3 months ]
    Change in the C-ACT score from baseline to the end of treatment

  2. Asthma Control Test (ACT) [ Time Frame: 3 months ]
    Change in the ACT score from baseline to the end of treatment

  3. Pediatric Asthma Quality of Life Questionnaire (PAQLQ) [ Time Frame: 3 months ]
    Change in the PAQLQ score from baseline to the end of treatment


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT03788395


Locations
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Italy
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, Italy, 90146
Sponsors and Collaborators
Istituto per la Ricerca e l'Innovazione Biomedica
More Information
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Responsible Party: Stefania La Grutta, MD, 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., Istituto per la Ricerca e l'Innovazione Biomedica
ClinicalTrials.gov Identifier: NCT03788395    
Other Study ID Numbers: 10/2018
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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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
Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents