AI and a smartphone app may let kids with asthma skip clinic visits

NCT ID NCT06062433

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial tests whether children aged 6 to 17 with asthma can manage their condition remotely using an artificial intelligence tool called the Asthma-Guidance and Prediction System, combined with a home monitoring device (AsthmaTuner). The goal is to see if this approach improves satisfaction with asthma care compared to usual clinic visits. Researchers will also measure how much time clinicians save in preparing for appointments.

What this could mean

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

Active substance
an AI-assisted clinical decision support system (Asthma-Guidance and Prediction System) paired with a home monitoring device (AsthmaTuner, a phone app and spirometer)
What this could lead to
If it works, this could point toward a more convenient, effective way for children with asthma to manage their condition from home, reducing clinic visits.
What could go wrong
This is a small, early feasibility trial with only 49 participants, so results may not apply broadly. The system relies on technology and patient engagement, which may not work for everyone.

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

49 people

The number who actually took part.

Started

Dec 2023

Finished

Jun 2025

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

6 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Clinician participants are eligible to be included in the study only if all of the following criteria apply: * Employed as consultant or nurse practitioner at study sites. * Able to provide written consent. * Are willing to follow recommendations to schedule/see participant and their caregiver for regular asthma follow-up care every 3-6 months. All asthma care coordinators who are involved in the usual care of pediatric participants will also be recruited for inclusion in the study. Pediatric participants are eligible to be included in the study only if all of the following criteria apply: * Ages 6-17 years old with diagnosis of asthma. * Have a caregiver who is willing to participate alongside pediatric participant and to have regular asthma follow-up care every 3-6 months. * Adolescent participants ages 13-17 years and their caregivers are able to give written informed consent; or child participants ages 7-12 years are able to provide assent and their caregivers are able to give written informed consent (subjects who are 6 years old will be waived). * Both participant and caregiver are able to read and write in English. * Receive pediatric primary care at study sites from participating study clinician. * Access for caregiver and/or adolescent participants to an Android or iPhone with Wi-Fi access and availability for at least monthly use. * Active asthma defined by at least one clinic visit with a diagnosis of asthma per EHR or on active asthma control or rescue medication in the past 12 months. Priority will be given to those with persistent asthma on inhaled corticosteroids therapy or those with poorly controlled asthma defined by any of the following criteria in the past 12 months, except item v (past 2-week period); i. Asthma Control Test for adolescents ≥ 12 years or Childhood Asthma Control Test for children \< 12 years (score\< 20); ii. ED visit for asthma; or iii. Hospitalization for asthma; or iv. Unscheduled outpatient visit for asthma requiring oral corticosteroid use; or v. Asthma symptoms at the screening interview, including 1) more than 2 days per week shortness of breath, wheezing, chest tightness, or 2) more than 1 night awakening due to asthma in the past 2-week period. * Participant had their latest asthma follow-up visit more than 3 months prior to the screening date of the study. Exclusion Criteria: Pediatric participants who do not meet the eligibility criteria described above will be excluded and those will be excluded from the study if any of the following criteria apply: * Major medical problems prohibiting study participation and inability to perform study procedures (including spirometry); suspected symptoms of exercise-induced laryngeal obstruction (EILO), tracheobronchial foreign body at or about the incidence date of asthma, wheezing occurring only in response to anesthesia or medications, bullous emphysema or pulmonary fibrosis on chest radiograph, PiZZ alpha1-antitrypsin, cystic fibrosis, or other major chest disease such as severe kyphoscoliosis or bronchiectasis. * Pediatric participant pregnancy. * Hyposensitization therapy for \> 3 months prior to study enrollment. * Participation in any other interventional studies for asthma within 1 month prior to study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

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