Albuterol Integrated Adherence Monitoring in Children With Asthma

Sponsor

Children's Hospital Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT04896645

Collaborator

Teva Pharmaceuticals USA (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Asthma in Children	Device: Digihaler Albuterol Device by TEVA	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Albuterol Integrated Adherence Monitoring in Children With Asthma

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients 8 to <19 years of age with a diagnosis of asthma 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.	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 Other Names: Electronic Adherence Monitor

Arm

Intervention/Treatment

Experimental: Patients 8 to <19 years of age with a diagnosis of asthma

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.

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

Other Names:

Electronic Adherence Monitor

Outcome Measures

Primary Outcome Measures

Asthma Outcomes [3 months]
Severity by NHLBI EPR3 Guidelines
Asthma Adherence [3 months]
4-item Morisky Medication Adherence Scale (MMAS-4)
Asthma Adherence [3 months]
Test of Adherence to Inhalers (TAI)
Asthma Outcomes [3 months]
Composite Asthma Severity Index (CASI)
Asthma Outcomes [3 months]
Asthma Control Test (ACT)
Albuterol Use [3 months]
Questionnaires created by investigators addressing when and how often albuterol is used for symptoms, illness, etc.

Secondary Outcome Measures

Spirometry [3 months]
Aluna at home gamified spirometer, measures full spirometry FEV1, FVC, FEV1/FVC, Peak Flow.
Lung Function [3 months]
Microlife FEV1, measures FEV1
Asthma Quality of Life [3 months]
PedsQL (Pediatric Quality of Life Inventory)

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Los Angeles	Los Angeles	California	United States	90027

Sponsors and Collaborators

Children's Hospital Los Angeles
Teva Pharmaceuticals USA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neema Izadi, Assistant Professor, Children's Hospital Los Angeles

ClinicalTrials.gov Identifier:

NCT04896645

Other Study ID Numbers:

CHLA-20-00013

First Posted:

May 21, 2021

Last Update Posted:

Mar 9, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Asthma

Albuterol

Study Results

No Results Posted as of Mar 9, 2022