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

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica (Other)
• Overall Status: Completed
• CT.gov ID: NCT03788395
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

• Study Type: Interventional
• 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: Jan 10, 2019
• Actual Primary Completion Date: Jan 23, 2020
• Actual Study Completion Date: Jan 23, 2020

Arms and Interventions

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

Primary Outcome Measures

1. Medication Adherence Rating Scale (MARS) [3 months]

   Change in the MARS score from baseline to the end of treatment

Secondary Outcome Measures

1. Childhood Asthma Control Test (C-ACT) [3 months]

   Change in the C-ACT score from baseline to the end of treatment

2. Asthma Control Test (ACT) [3 months]

   Change in the ACT score from baseline to the end of treatment

3. Pediatric Asthma Quality of Life Questionnaire (PAQLQ) [3 months]

   Change in the PAQLQ score from baseline to the end of treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Dec 27, 2018
• Last Update Posted: Jun 9, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Asthma; Budesonide, Formoterol Fumarate Drug Combination

Study Results

No Results Posted as of Jun 9, 2020