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Can a phone app and inhaler sensors tame childhood asthma?

NCT ID NCT06820593

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a mobile app, inhaler sensors, and remote coaching from an asthma coordinator can help children ages 4-17 better manage their asthma. Eighty parent-child pairs will be split into two groups: one gets the full digital toolkit with coaching, the other gets only the sensors without app features. The goal is to see if this approach is practical and acceptable for improving asthma control at home.

What this could mean

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

Active substance
Digital Asthma Intervention (mHealth app and sensors) with remote patient monitoring
What this could lead to
If successful, this could show that combining a smartphone app, inhaler sensors, and remote coaching helps children better manage their asthma and reduces symptoms.
What could go wrong
This is a small feasibility study with only 80 participants, so results may not apply to all children. The intervention relies on technology and caregiver 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

About 80 people

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

Started

Mar 2025

Expected to finish

Jan 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

4 years and older

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 into the study will not depend on sex, ethnicity, or race. We will monitor enrollment to ensure a diversity of sex and race/ethnicity are represented. PARENT-CHILD PAIR INCLUSION CRITERIA 1. Caregivers must be at least 18 years old (defined as parent or legal guardian) 2. The child (patient) has a diagnosis of asthma associated with a clinic visit in the electronic health record 3. The child is between the ages of 4-17 years old at the time of recruitment 1. The study is interested in the self-management of asthma by caregivers, whom are still primarily responsible for their child's chronic disease management. 2. Children younger than 4 years old will not be included in this study as the diagnosis of asthma is typically difficult to confirm in younger ages. 4. The child is prescribed inhaled corticosteroid or corticosteroid/long-acting beta agonist combination for daily use. The patient can have an inhaled corticosteroid/long-acting beta agonist for both daily preventive and rescue use, as in Single Maintenance and Reliever Therapy (SMART). 5. Persistent or un controlled asthma based on NHLBI guidelines40; Any 1 of the following: 1. In past month, \>2 days per week with asthma symptoms 2. \>2 days per week with rescue medication use 3. \>2 days per month with nighttime awakenings (for children who are not taking a controller asthma medication) OR \>2 days per month with nighttime awakenings (for children who are currently taking a controller asthma medication) 4. \>2 asthma episodes during the past year that required systemic corticosteroids 6. The child is a patient in Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH PARENT-CHILD PAIR EXCLUSION CRITERIA 1. The caregiver has a smartphone that is not compatible with the Hailie® app. 2. The patient is prescribed a controller (preventive) or rescue inhaler medication to which the Hailie electronic sensor cannot affix. 3. The caregiver is unable to speak and understand English. a. With this trial, the intent is to first establish feasibility and broaden to different languages in future. 4. The child has clinically significant, comorbid diagnoses, such as cystic fibrosis, cyanotic heart disease, or bronchopulmonary dysplasia, that could interact with their assessment of asthma-related measures. 5. The family has active Department of Child and Family Services (DCFS) involvement 6. The participant is enrolled in another asthma intervention study at the time of enrollment to this study. 7. Child or sibling living in the same home was previously enrolled in this study. 8. Consent is not obtained from the parent/guardian. 9. Parent/guardian does not pass the test of understanding at study enrollment. HEALTH CARE PROVIDER INCLUSION CRITERIA (IMPLEMENTATION OUTCOMES) 1. Participant is an employee of LCH system 2. Works at or supports the operations of Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH 3. Able to provide informed consent HEALTH CARE PROVIDER EXCLUSION CRITERIA (IMPLEMENTATION OUTCOMES) 1\. Participant departs LCH and is no longer an active employee at the time of assessment

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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.

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

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Contacts and locations

Locations

  • Ann & Robert H Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

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