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Albuterol Integrated Adherence Monitoring in Children With Asthma

Primary Purpose

Asthma in Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digihaler Albuterol Device by TEVA
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma in Children

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept 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).

Sites / Locations

  • Children's Hospital Los Angeles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2021
Last Updated
February 7, 2023
Sponsor
Children's Hospital Los Angeles
Collaborators
Teva Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT04896645
Brief Title
Albuterol Integrated Adherence Monitoring in Children With Asthma
Official Title
Albuterol Integrated Adherence Monitoring in Children With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
Teva Pharmaceuticals USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients 8 to <19 years of age with a diagnosis of asthma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Digihaler Albuterol Device by TEVA
Other Intervention Name(s)
Electronic Adherence Monitor
Intervention Description
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
Primary Outcome Measure Information:
Title
Asthma Outcomes
Description
Severity by NHLBI EPR3 Guidelines
Time Frame
3 months
Title
Asthma Adherence
Description
4-item Morisky Medication Adherence Scale (MMAS-4)
Time Frame
3 months
Title
Asthma Adherence
Description
Test of Adherence to Inhalers (TAI)
Time Frame
3 months
Title
Asthma Outcomes
Description
Composite Asthma Severity Index (CASI)
Time Frame
3 months
Title
Asthma Outcomes
Description
Asthma Control Test (ACT)
Time Frame
3 months
Title
Albuterol Use
Description
Questionnaires created by investigators addressing when and how often albuterol is used for symptoms, illness, etc.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Spirometry
Description
Aluna at home gamified spirometer, measures full spirometry FEV1, FVC, FEV1/FVC, Peak Flow.
Time Frame
3 months
Title
Lung Function
Description
Microlife FEV1, measures FEV1
Time Frame
3 months
Title
Asthma Quality of Life
Description
PedsQL (Pediatric Quality of Life Inventory)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Albuterol Integrated Adherence Monitoring in Children With Asthma

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