Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities

Launched by CHILDREN'S HOSPITAL LOS ANGELES · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a smart inhaler to help adolescents with asthma who also have intellectual and developmental disabilities. The goal is to see if using this new technology makes it easier for these young people to correctly use their inhalers, which is crucial for managing their asthma. The smart inhaler provides guidance and feedback on how to use it properly, and researchers want to find out if this leads to better asthma control and improved lung function.

To participate in the study, adolescents aged 10 to 17 years with a diagnosis of mild-to-moderate intellectual disability or autism, along with moderate-to-severe asthma, may be eligible. They must be able to understand the study process with the help of their parent or guardian, who will also need to provide consent. Throughout the trial, participants will use the smart inhaler daily, and researchers will monitor how well it works for them. This study hopes to improve asthma management for this specific group of young people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria: Participants must meet all of the inclusion criteria to participate in this study:
• • Adolescents ages 10-17 years
• • Diagnosis of mild-to-moderate intellectual disability: ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89
• • Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma: ICD-10: J45.40-J45.909
• • 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 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): Ventolin HFA, ProAir HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA.
• Exclusion Criteria: All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:
• • Health status or any clinical conditions: Limited life expectancy, co-existing disease or other characteristics that precludes appropriate diagnosis, treatment, or follow-up in the trial.
• • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.