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Smart Inhaler Use for Asthma in Adolescents with Intellectual and Developmental Disabilities

This study is looking at how smart inhalers can help adolescents (ages 10-17) with intellectual and developmental disabilities (IDD), including autism, manage their asthma. These smart inhalers give feedback on how to use asthma medications correctly. The study wants to see if using smart inhalers is practical and well-liked by this group, if it helps them use their inhalers better, and if it improves their lung function. You could join if you are 10-17 years old, have a diagnosis of mild-to-moderate intellectual disability or developmental disability (like autism), and have moderate-to-severe asthma. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is a single-blinded (you won't know if you're getting the smart inhaler or standard education) randomized-controlled pilot study with a goal of 30 participants.
What's involved
You would attend three visits over 8 weeks, with each visit scheduled four weeks apart. If in the intervention group, you would use a smart inhaler daily for 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary goals are measured at weeks 1-8, and weeks 4 and 8. The study involves three visits over 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06783101

Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities

Recruiting
NAAges 10–17InterventionalTreatment
Children's Hospital Los Angeles
~30 participants
Updated 2025-01-20 on ClinicalTrials.gov
What's tested:Use of smart inhaler to enhance asthma inhaler proficiency

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of smart inhaler device
Measured over Weeks 1-8
+2 more outcomes measured

Conditions

Asthma in Children
Intellectual Disabilities (F70-F79)
Developmental Disability
Autism Spectrum Disorder (ASD)

Explore related trials

AsthmaAutism Spectrum DisorderIntellectual Disability

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Larry Yin, MD, MSPH · PRINCIPAL_INVESTIGATOR · Children's Hospital Los Angeles

Who to contact

Sophia Park, MD
[email protected]
323-669-2534
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adolescents ages 10-17 years
Diagnosis of mild-to-moderate intellectual disability: ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89
Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma: ICD-10: J45.40-J45.909
Parent/legal guardian is willing to answer questions about their child.
Parent/legal guardian and adolescent must have the ability to understand study procedures and to comply with them for the entire length of the study
English or Spanish-speaking participants
Not involved in other studies using digital inhalers
Males and females of reproductive capability will be enrolled: contraception is not necessary or required.
Participants must use any of the following MDIs (as indicated by the 510(k): Ventolin HFA, ProAir HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA.

Exclusion

Health status or any clinical conditions: Limited life expectancy, co-existing disease or other characteristics that precludes appropriate diagnosis, treatment, or follow-up in the trial.
Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

What this trial measures

  • Feasibility of smart inhaler deviceWeeks 1-8

    Feasibility will be determined by data completeness: Ratio of days on which there are valid smart inhaler data out of the total number of days

  • Acceptability of smart inhalerWeeks 4 and 8

    Acceptability will be measured by response rate on user satisfaction survey.

  • Usability of smart inhalerWeeks 4 and 8

    Usability will be measured by ease of use smart inhaler survey.