Recruiting

Smart Inhalers

Sponsor:

Children's Hospital Los Angeles

Code:

NCT07746921

Conditions

Asthma in Children

Intellectual Disabilities (F70-F79)

Developmental Disability

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Use of active remote smart inhaler in the home setting

Use of passive remote smart inhaler in the home setting

Study Details

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 for remote home use. This study aims to investigate whether daily application of smart inhalers (1) is feasible, acceptable and usable in the IDD population for remote asthma management, (2) improves the rate of medication use and correct medication administration, and (3) results in improvement in lung function. This effort aims to promote better asthma management in the IDD population for remote home use.

Conditions

Asthma in Children

Intellectual Disabilities (F70-F79)

Developmental Disability

Autism Spectrum Disorder

Study ID

NCT07746921

Start date

Aug 10, 2026

Status verified date

Aug, 2026

Completion date

Aug 9, 2027

Anticipated

Primary completion date

Aug 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adolescents ages 10-17 years
  • Diagnosis of mild-to-moderate intellectual disability (ID) ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89; (Diagnosis of ID and/or autism in the EMR may be used to reach out to potential families).
  • Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma or diagnosis indicated in the EMR: ICD-10: J45.40-J45.909; (Diagnosis of ID and/or autism in the EMR may be used to reach out to potential families).
  • Parent/legal guardian has a smartphone and is willing to download an application associated with the CapMedic device, is assigned to the intervention group.
  • 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 currently 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) as maintenance inhaled corticosteroids (ICS): Advair HFA, Flovent HFA, Symbicort HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA.

Exclusion Criteria:

  • Health status or any clinical conditions: limited life expectancy and complex respiratory pathologies (e.g., tracheostomy, restrictive lung disease, bronchopulmonary dysplasia, cystic fibrosis) to prevent confounding in asthma treatment outcomes.
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Comparator

Standard asthma education arm and passive smart inhaler every day for 8 weeks in the home setting.

experimental: Intervention

Uses active smart inhaler daily for 8 weeks in the home setting.

Interventions

Use of active remote smart inhaler in the home setting

The application of the remote smart inhaler in active setting to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.

Use of passive remote smart inhaler in the home setting

The application of the passive remote smart inhaler to evaluate feasibility, acceptability, and usability on inhaler use proficiency in the home setting.

Primary outcome measure

  • Feasibility of smart inhaler device for remote home management [ Time Frame: Weeks 1-8 ]
  • Acceptability of smart inhaler for remote home management [ Time Frame: Weeks 4 and 8 ]
  • Usability of smart inhaler for remote home management [ Time Frame: Weeks 4 and 8 ]

Central Contacts and Locations

Central contacts

Alexis Deavenport-Saman, DrPH, MPH

323-361-2994adeavenport@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Alexis Deavenport-Saman, DrPH, MPH

323-294-3233adeavenport@chla.usc.edu

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • smart inhaler
  • asthma
  • remote home management
  • medication adherence
  • intellectual disability
  • developmental disability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2026-08-31.