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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04896645
Other study ID # CHLA-20-00013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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