NCT06783101 Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities
| NCT ID | NCT06783101 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Los Angeles |
| Condition | Asthma in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-08-13 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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. This study aims to investigate whether daily application of smart inhalers (1) is feasible and acceptable in the IDD population, (2) improves the rate of correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population.
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.
Contact & Investigator
Larry Yin, MD, MSPH
PRINCIPAL INVESTIGATOR
Children's Hospital Los Angeles
Frequently Asked Questions
Who can join the NCT06783101 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 17 Years, studying Asthma in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06783101 currently recruiting?
Yes, NCT06783101 is actively recruiting participants. Contact the research team at soppark@chla.usc.edu for enrollment information.
Where is the NCT06783101 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06783101 clinical trial?
NCT06783101 is sponsored by Children's Hospital Los Angeles. The principal investigator is Larry Yin, MD, MSPH at Children's Hospital Los Angeles. The trial plans to enroll 30 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.