An interventional study of Use of active remote smart inhaler in the home setting and Use of passive remote smart inhaler in the home setting in Asthma in Children, Intellectual Disabilities (F70-F79) and Developmental Disability, sponsored by Children's Hospital Los Angeles. Recruiting at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment
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.
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.
387 studies on the registry are indexed under Intellectual Disability; 105 are open to participants now.
This study's planned enrollment of 34 is below the median of 58 across 248 interventional studies indexed under Intellectual Disability.
Browse Intellectual Disability studies →Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard asthma education arm and passive smart inhaler every day for 8 weeks in the home setting.
Behavioral: Use of passive remote smart inhaler in the home setting
Uses active smart inhaler daily for 8 weeks in the home setting.
Behavioral: Use of active remote smart inhaler in the home setting
The application of the remote smart inhaler in active setting to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.
The application of the passive remote smart inhaler to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.
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
Time frame: 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).
Time frame: 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).
Time frame: Weeks 4 and 8
Change in fractional exhaled nitric oxide (FeNO) levels
Examine changes in FeNO levels from FeNO test, measured in parts per billion (ppb).
Time frame: 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)
Time frame: Weeks 1,4,8
Change in peak expiratory flow (PEF)
Examine changes in PEF using a spirometer, measured in liters/minute (l/m)
Time frame: 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.
Time frame: Weeks 1, 4, 8
Correlation of change in medication adherence and lung function.
Examine change in association of medication use, with 1= yes and 0=1, (min=0, max=1) for each day of use, and correlation with lung function, measured by FeNO levels or parts per billion (ppb).
Time frame: Weeks 1,4,8
Correlation of change in Inhaler proficiency score and forced expiratory volume in 1 second (FEV1).
Validated 9-step Inhaler Proficiency Scale (IPS), measured from a score of 0-9 (min=0, max=9) and correlation with FEV1, measured in liters/minute (l/m).
Time frame: Weeks 1,4,8
Correlation of change in Inhaler proficiency score and peak expiratory flow (PEF)
Validated 9-step Inhaler Proficiency Scale (IPS), measured from a score of 0-9 (min=0, max=9) and correlation with PEF, measured in liters/minute (l/m).
Time frame: Weeks 1,4,8
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Aug 2026; primary completion for Aug 2027, 11 months later.
Of 155 non-industry interventional studies with no phase under Intellectual Disability, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 11 months is below that.
Counting every sponsor, half of 158 studies reached it within 19 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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