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Smart inhaler cap aims to bridge asthma care gap for teens with disabilities

NCT ID NCT07746921

Disease control Sponsor: Children's Hospital Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This pilot trial tests whether a digital inhaler cap, which gives real-time guidance on inhaler technique, can help adolescents with intellectual and developmental disabilities (IDD) manage their asthma at home. The study will compare active use of the smart inhaler to passive use, measuring feasibility, acceptability, and usability, as well as changes in medication use and lung function. If the device proves practical and effective, it could offer a new way to support asthma management in this population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A digital inhaler cap that provides guidance and feedback on inhaler technique, used actively or passively in the home setting.
What this could lead to
If successful, this could lead to a practical tool that helps teens with intellectual and developmental disabilities use their asthma inhalers correctly, improving asthma control and reducing hospital visits.
What could go wrong
This is a small pilot study, so results may not apply to everyone. The device may be hard for some teens to use, and it's unclear if it will actually improve lung function or medication use in the long run.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adolescents ages 10-17 years * Diagnosis of mild-to-moderate intellectual disability (ID) ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89; (Diagnosis of ID and/or autism in the EMR may be used to reach out to potential families). * Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma or diagnosis indicated in the EMR: ICD-10: J45.40-J45.909; (Diagnosis of ID and/or autism in the EMR may be used to reach out to potential families). * Parent/legal guardian has a smartphone and is willing to download an application associated with the CapMedic device, is assigned to the intervention group. * 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 currently 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) as maintenance inhaled corticosteroids (ICS): Advair HFA, Flovent HFA, Symbicort HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA. Exclusion Criteria: * Health status or any clinical conditions: limited life expectancy and complex respiratory pathologies (e.g., tracheostomy, restrictive lung disease, bronchopulmonary dysplasia, cystic fibrosis) to prevent confounding in asthma treatment outcomes. * Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

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Conditions

The condition(s) this trial relates to.

asthma autism spectrum disorder childhood onset asthma developmental disability intellectual disability Medication Adherence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma in children Autism spectrum disorder Developmental disability Intellectual disabilities (F70-F79)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

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Other studies related to the condition(s) this trial covers.