Smart Inhaler and Remote Asthma Management in Adolescents With Intellectual and Developmental Dis… (NCT07746921) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Smart Inhaler and Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities
United States34 participantsStarted 2026-08-10
Plain-language summary
Correct use of daily medications containing inhaled corticosteroids is key for asthma control, yet children with intellectual and developmental disabilities (IDD) face additional barriers to proper inhaler use. Smart inhalers, a novel technology that provides guidance and immediate feedback on inhaler use techniques, have been shown to enhance correct medication administration in the typically developing pediatric population, but their effectiveness has not been evaluated on the pediatric IDD population for remote home use. This study aims to investigate whether daily application of smart inhalers (1) is feasible, acceptable and usable in the IDD population for remote asthma management, (2) improves the rate of medication use and correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population for remote home use.
Who can participate
Age range
10 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 lu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is not yet recruiting, how soon might it open and would it make sense to manage my child's asthma with standard care in the meantime while we wait to see if we can enroll?
2This study is focused on whether a smart inhaler is feasible, acceptable, and usable for teens with intellectual and developmental disabilities — not on proving it improves asthma outcomes — so what does that mean for what my child would actually gain medically by participating?
3My child has both asthma and an intellectual or developmental disability like autism — how would you assess whether they have the specific combination of needs this trial seems designed for, and are there any inclusion or exclusion criteria I should understand before pursuing this?
4Since the trial involves remote home monitoring through a smart inhaler device, what would that actually look like day-to-day for my child and our family, and do you think the burden of using and tracking a new device is realistic given my child's current abilities?
5Are there existing proven treatments or asthma management programs for adolescents with developmental disabilities that we should consider first, or alongside this trial, before committing to a study that is still in the feasibility-testing stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of smart inhaler device for remote home management
Timeframe: Weeks 1-8
2
Acceptability of smart inhaler for remote home management
Timeframe: Weeks 4 and 8
3
Usability of smart inhaler for remote home management