Asthma in ChildrenIDDNCT07746921
Smart Inhaler and Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities
A study testing Use of active remote smart inhaler in the home setting and Use of passive remote smart inhaler in the home setting in people with Asthma in Children and Intellectual Disabilities (F70-F79), run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Asthma in Children, Intellectual Disabilities (F70-F79), Developmental Disability
- What is being tested?
- Use of active remote smart inhaler in the home setting and Use of passive remote smart inhaler in the home setting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2026to 9 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Alexis Deavenport-Saman, DrPH, MPH, 323-294-3233, adeavenport@chla.usc.edu
About this study
Official title: A Pilot Randomized Controlled Trial: Utilizing a Digital Inhaler Cap to Support for Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities
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.
Read the detailed description
The study is a single-blinded randomized-controlled pilot trial with a goal of 34 participants ages 10-17 years diagnosed with IDD and moderate-to-severe asthma. Subjects are recruited from subspecialty clinics and a primary care FQHC at a large, urban academic children's hospital. Participants in the intervention group are assigned to use active smart inhalers for remote home management daily for 8 weeks, and the control group receives standard asthma education and passive smart inhalers for remote home management.
All participants attend three visits over 8 weeks, each scheduled four weeks apart. Primary outcomes, feasibility and acceptability, are assessed by data completeness and satisfaction surveys. Secondary outcomes, medication reminders, the Inhaler Proficiency Scales, are measured by the smart inhaler and by a trained observer and analyzed by Spearman's correlation test. Tertiary outcomes, Forced Expiratory Volume (FEV1) in one second, and Peak Expiratory Flow (PEF), are measured by a spirometer. Fractional exhaled nitric oxide (FeNO), which measures the amount of nitric oxide exhaled from a breath in parts per billion, will be measured by a FeNO device. Demographics and outcomes are reported as frequencies (%), mean (SD), or median (IQR). Analyses will utilize generalized linear mixed-effects models to account for the within-participant correlation.
- Conditions
- Asthma in Children, Intellectual Disabilities (F70-F79), Developmental Disability, Autism Spectrum Disorder
- Being tested
- Use of active remote smart inhaler in the home setting, Use of passive remote smart inhaler in the home setting
- Keywords
- smart inhaler, asthma, remote home management, medication adherence, intellectual disability, developmental disability
- Medical subject headings
- Intellectual Disability, Developmental Disabilities, Autism Spectrum Disorder, Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of active remote smart inhaler in the home settingBehavioural
The application of the remote smart inhaler in active setting to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.
Use of passive remote smart inhaler in the home settingBehavioural
The application of the passive remote smart inhaler to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Experimental | Standard asthma education arm and passive smart inhaler every day for 8 weeks in the home setting. Receives: Behavioral: Use of passive remote smart inhaler in the home setting |
| Intervention | Experimental | Uses active smart inhaler daily for 8 weeks in the home setting. Receives: Behavioral: Use of active remote smart inhaler in the home setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of smart inhaler device for remote home management
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
Measured: Weeks 1-8
Acceptability of smart inhaler for remote home management
Acceptability will be measured by response rate on user satisfaction survey item, measured on a 5-pt Likert type scale, ranging from very unsatisfied to very satisfied, with a score of 1-5 (min=1, max= 5).
Measured: Weeks 4 and 8
Usability of smart inhaler for remote home management
Usability will be measured by an "ease of use" smart inhaler survey item, and will be measured on a 5-pt Likert type scale, ranging from very hard to very easy, with a score of 1-5 (min=1, max= 5).
Measured: Weeks 4 and 8
Secondary outcomes (4)
Change in fractional exhaled nitric oxide (FeNO) levels
Examine changes in FeNO levels from FeNO test, measured in parts per billion (ppb).
Measured: Weeks 1,4,8
Change in forced expiratory volume in 1 second (FEV1)
Examine changes in FEV1 using a spirometer, measured in liters/minute (l/m)
Measured: Weeks 1,4,8
Change in peak expiratory flow (PEF)
Examine changes in PEF using a spirometer, measured in liters/minute (l/m)
Measured: Weeks 1,4,8
Correlation of change in Inhaler proficiency score and medication adherence
Validated 9-step Inhaler Proficiency Scale (IPS), measured from a score of 0-9 (min=0, max=9) and correlation with medication use, with 1= yes and 0=1, (min=0, max=1) for each day of use.
Measured: Weeks 1, 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion9 Aug 2027 (estimated)
- Study completion9 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Yin, Children's Hospital Los Angeles
- Investigators
- Larry Yin, MD, MSPH, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746921
- Sponsor's protocol ID
- CHLA-26-00026
- Acronym
- IDD
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No