Smart Inhaler Use at Home for Adolescents with IDD and Asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized trial will enroll 34 adolescents aged 10–17 with intellectual or developmental disabilities and moderate-to-severe asthma. Participants are assigned to either active smart inhalers for home use or passive smart inhalers plus standard education for 8 weeks, with three study visits. Primary goals are to see if the approach is feasible and acceptable, using data completeness and satisfaction surveys. Secondary goals look at whether medication use and correct technique improve, as measured by the inhalers and trained observers. Tertiary outcomes include lung function tests (FEV1, PEF) and FeNO, analyzed with models that account for repeated measures.

Why it matters

Who can join: the full rules

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 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.

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Larry Yin, MD, MSPH — Children's Hospital Los Angeles
• Study coordinator: Alexis Deavenport-Saman, DrPH, MPH
• Email: adeavenport@chla.usc.edu
• Phone: 323-361-2994

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.