NCT06783101Recruiting
Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities
A Pilot Randomized Controlled Trial: Utilizing a Digital Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities
Source: ClinicalTrials.gov · Last updated 20 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- 13 Aug 2024
- Primary completion date
- Apr 2025
- Lead sponsor
- Children's Hospital Los Angeles
- NCT number
- NCT06783101
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 13 Aug 2024 to the primary completion date, Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Who the study is looking for
- 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.
Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.