Albuterol Integrated Adherence Monitoring in Children With Asthma

Asthma in Children Clinical Trial

Official title:

Albuterol Integrated Adherence Monitoring in Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04896645
• Other study ID #: CHLA-20-00013
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 22, 2022

Study information

• Verified date: November 2023
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose to evaluate whether an integrated electronic adherence monitoring albuterol rescue inhaler can improve proper use in a mostly minority and inner-city population of children treated for asthma at the Children's Hospital of Los Angeles

Description:

This study is designed to (1) determine whether an integrated EAM albuterol rescue inhaler can increase proper use (2) determine if the monitoring capabilities of the device (flow rate, warnings) and/or increased proper use from having the device correlate with better outcomes. The investigators will also have patients perform at-home gamified spirometry (Aluna ©) to (3) determine if at-home spirometry can predict albuterol use or change outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients 8 to <19 years of age with a diagnosis of asthma as ICD-9 code 493 or ICD-10 code J45 seen in the allergy clinic at CHLA who have an albuterol rescue inhaler already prescribed and access to a personal smartphone will be eligible for recruitment.

Exclusion Criteria:

• Patients unable to use device, unable to use albuterol (i.e. must use levalbuterol) or Age < 4 (ProAir® Digihaler only approved for Subjects 4 years and older). Patients with other chronic lung disease besides asthma or other significant comorbidities that could affect lung function/asthma (e.g. significant heart defects, immunodeficiency, cystic fibrosis, etc).

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Device:
• Digihaler Albuterol Device by TEVA
Patient with asthma will have their regular albuterol rescue inhaler replaced with Digihaler, they will also be asked to perform gamified spirometry (Aluna) at home

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	Teva Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Outcomes	Severity by NHLBI EPR3 Guidelines	3 months
Primary	Asthma Adherence	4-item Morisky Medication Adherence Scale (MMAS-4)	3 months
Primary	Asthma Adherence	Test of Adherence to Inhalers (TAI)	3 months
Primary	Asthma Outcomes	Composite Asthma Severity Index (CASI)	3 months
Primary	Asthma Outcomes	Asthma Control Test (ACT)	3 months
Primary	Albuterol Use	Questionnaires created by investigators addressing when and how often albuterol is used for symptoms, illness, etc.	3 months
Secondary	Spirometry	Aluna at home gamified spirometer, measures full spirometry FEV1, FVC, FEV1/FVC, Peak Flow.	3 months
Secondary	Lung Function	Microlife FEV1, measures FEV1	3 months
Secondary	Asthma Quality of Life	PedsQL (Pediatric Quality of Life Inventory)	3 months