34 Participants NeededMy employer runs this trial

Smart Inhaler for Asthma

(IDD Trial)

AD
Overseen ByAlexis Deavenport-Saman, DrPH, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Los Angeles
Must be taking: Inhaled corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smart inhaler for children with asthma who also have intellectual or developmental disabilities (IDD), such as autism. The smart inhaler guides users to take their medicine correctly by providing guidance and feedback. The trial aims to determine if using this inhaler at home can improve medication adherence and asthma management. It seeks participants aged 10-17 with moderate-to-severe asthma and IDD, whose parents have a smartphone and are willing to use an app linked to the inhaler. Participants will use either a smart inhaler that provides active feedback or one that only monitors use for eight weeks. As an unphased trial, this study offers a unique opportunity to contribute to innovative asthma care solutions for children with IDD.

What prior data suggests that this smart inhaler is safe for children with IDD?

Research has shown that smart inhalers are generally safe for people with asthma. These devices assist users in taking their medication correctly by providing feedback on inhaler use. Studies have examined the role of smart inhalers in helping people adhere to their treatment plans and found them effective.

Although specific information about side effects of smart inhalers is lacking, they resemble regular inhalers, which are widely used and considered safe. The primary difference is that smart inhalers include digital features, such as tracking usage and sending reminders, to enhance treatment. Therefore, any risks would likely mirror those of regular inhalers, which are usually well-tolerated.

In summary, smart inhalers seem to be a safe option for managing asthma, particularly for those who need assistance in taking their medication consistently.12345

Why are researchers excited about this trial?

Researchers are excited about the smart inhaler for asthma because it offers a fresh approach to managing the condition. Unlike traditional inhalers, which rely solely on the user’s ability to remember and properly use them, the smart inhaler integrates technology to actively track and remind patients about their medication usage. This means users can receive real-time feedback and maintain better control over their asthma. This tech-savvy approach not only aims to improve adherence but could also lead to more personalized asthma management by collecting valuable usage data.

What evidence suggests that the smart inhaler is effective for asthma management in children with IDD?

Research has shown that smart inhalers can effectively manage asthma. One study found that people using a digital inhaler system were 85.3% more likely to control their asthma better than those who did not use it. Another study demonstrated that smart inhalers reduced asthma flare-ups and improved adherence to medication plans. Although some studies reported mixed results regarding asthma control and quality of life, the overall evidence suggests that smart inhalers support proper medication use and asthma management.

In this trial, researchers will divide participants into two groups: one group will use an active smart inhaler daily for 8 weeks, while the other group will receive standard asthma education and use a passive smart inhaler. This approach could be particularly beneficial for children with intellectual and developmental disabilities, who may find it more challenging to use inhalers correctly.678910

Who Is on the Research Team?

LY

Larry Yin, MD, MSPH

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for adolescents with asthma who also have intellectual or developmental disabilities, including autism. Participants should be able to use an inhaler at home and need help managing their asthma medication.

Inclusion Criteria

I use one of the specified inhalers daily for my condition.
English or Spanish-speaking participants
I am between 10 and 17 years old.
See 7 more

Exclusion Criteria

I am unable or unwilling to provide written consent for this study.
I do not have a limited life expectancy or complex lung conditions like cystic fibrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use smart inhalers daily for remote home management

8 weeks
3 visits (in-person), each 4 weeks apart

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Smart Inhaler

Trial Overview

The study compares two types of smart inhalers—one that gives feedback automatically (passive) and one that requires user interaction (active)—to see if they help kids with IDD use their asthma medicine correctly at home.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention
Group II: ComparatorExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials
257
Recruited
5,075,000+

Citations

Effectiveness, usability and acceptability of a smart inhaler ...

This study aims to investigate the effectiveness of a smart inhaler asthma self-management programme on medication adherence and clinical outcomes in adults ...

Effectiveness of a Digital Inhaler System for Patients With ...

In this study, participants using the RDS had greater odds of clinically meaningful improvements in asthma control versus SoC after 3 months.

Evidence reviews for smart inhalers - NCBI Bookshelf

In terms of outcomes, the smart device resulted in fewer exacerbations, but poorer asthma control and quality of life compared to a device without feedback.

Opportunities and Challenges in the Implementation of ...

Evidence from adult and paediatric studies indicates that smart inhalers can improve adherence. They may also improve self-management; The ...

Cost Analysis of SMART Therapy to Improve Asthma ...

Studies show that using a single inhaler reduces the risk of asthma flare-ups by about 30%, compared to using one daily maintenance inhaler ...

Safety of regular formoterol or salmeterol in adults with asthma

Complete all‐cause SAE outcome data were obtained ... Although individual participant results in relation to death from asthma have been reported for SMART ...

Smart stethoscopes, smart inhalers, and ChatGPT

ABSTRACT. Asthma is the most common chronic disease in children, yet outcomes remain suboptimal, with high rates of exacerbations, emergency visits, ...

M16 Real-world outcomes from use of Enerzair inhalers ...

Aim To review adherence assessment outcomes at a regional severe asthma service for patients using an Enerzair inhaler with Propeller monitor connected inhaler ...

Building bridges for meaningful ehealth

This study aims to investigate the effectiveness of a smart inhaler asthma self- management programme on medication adherence and clinical outcomes in adults.

Smart Inhaler Market | Global Market Analysis Report - 2036

Connected Smart Inhalers holds 52% of the product segment in 2026. Asthma Management represents 56% of the application segment in 2026.