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OpenTrials
Completed

NCT Number: NCT04896645

Albuterol Integrated Adherence Monitoring in Children With Asthma

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

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Key information

Conditions

Asthma in Children

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Digihaler Albuterol Device by TEVA

Device

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

Primary outcomes

  1. Asthma Outcomes

    Time frame: 3 months

    Severity by NHLBI EPR3 Guidelines

  2. Asthma Adherence

    Time frame: 3 months

    4-item Morisky Medication Adherence Scale (MMAS-4)

  3. Asthma Adherence

    Time frame: 3 months

    Test of Adherence to Inhalers (TAI)

  4. Asthma Outcomes

    Time frame: 3 months

    Composite Asthma Severity Index (CASI)

  5. Asthma Outcomes

    Time frame: 3 months

    Asthma Control Test (ACT)

  6. Albuterol Use

    Time frame: 3 months

    Questionnaires created by investigators addressing when and how often albuterol is used for symptoms, illness, etc.

Secondary outcomes

  1. Spirometry

    Time frame: 3 months

    Aluna at home gamified spirometer, measures full spirometry FEV1, FVC, FEV1/FVC, Peak Flow.

  2. Lung Function

    Time frame: 3 months

    Microlife FEV1, measures FEV1

  3. Asthma Quality of Life

    Time frame: 3 months

    PedsQL (Pediatric Quality of Life Inventory)

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • Teva Pharmaceuticals USA

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 21, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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