Using smart inhalers to help adolescents with asthma and intellectual disabilities

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 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.

Why it matters

Who can join: the full rules

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 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: Sophia Park, MD
• Email: soppark@chla.usc.edu
• Phone: 323-669-2534

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.