Using smart inhalers to help adolescents with asthma and intellectual disabilities
A Pilot Randomized Controlled Trial: Utilizing a Digital Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities
This study is testing if smart inhalers can help teenagers with asthma and intellectual disabilities manage their condition better than just standard education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06783101 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of smart inhalers to improve asthma management in adolescents aged 10-17 with intellectual and developmental disabilities (IDD). It is a single-blinded randomized-controlled pilot trial involving 30 participants who will use smart inhalers daily for 8 weeks, while a control group receives standard asthma education. The study aims to assess the feasibility and acceptability of smart inhalers, their impact on correct medication administration, and improvements in lung function. Participants will attend three visits over the study period to evaluate various outcomes related to inhaler proficiency and lung function.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-17 with a diagnosis of mild-to-moderate intellectual disability and moderate-to-severe asthma.
Not a fit: Patients who are not diagnosed with intellectual or developmental disabilities or those with mild asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance asthma management and quality of life for adolescents with intellectual and developmental disabilities.
How similar studies have performed: While smart inhalers have shown promise in typically developing children, their effectiveness in the IDD population is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California
- 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: Sophia Park, MD
- Email: soppark@chla.usc.edu
- Phone: 323-669-2534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.