Albuterol Integrated Adherence Monitoring in Children With Asthma

NCT04896645 | Completed

• 1 other identifier: CHLA-20-00013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (6)

• Asthma Outcomes

  Severity by NHLBI EPR3 Guidelines

  3 months

• Asthma Adherence

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

  3 months

• Asthma Adherence

  Test of Adherence to Inhalers (TAI)

  3 months

• Asthma Outcomes

  Composite Asthma Severity Index (CASI)

  3 months

• Asthma Outcomes

  Asthma Control Test (ACT)

  3 months

• Albuterol Use

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

  3 months

Secondary Outcomes (3)

• Spirometry

  3 months

• Lung Function

  3 months

• Asthma Quality of Life

  3 months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

Also known as: Electronic Adherence Monitor

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

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Study Officials

• Neema Izadi, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 21, 2021
• Study Start: June 1, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)