Smart Inhaler for Childhood Asthma

(IDD Trial)

Recruiting in Los Angeles (>99 mi)

Overseen By Alexis Deavenport-Saman, DrPH, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Must be taking: Inhaled corticosteroids

Disqualifiers: Limited life expectancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, participants must use one of the specified inhalers like Ventolin HFA or Advair HFA, so you may need to continue using these if they are part of your current treatment.

What data supports the effectiveness of the Smart Inhaler treatment for childhood asthma?

Research suggests that smart inhalers, which provide immediate feedback on how well children use their inhalers, can help improve asthma control by ensuring better adherence to medication and proper inhalation technique. This is important because many children with asthma do not use their inhalers correctly, which can lead to poor asthma control. ^{1 2 3 4 5}

Is the Smart Inhaler safe for children with asthma?

There is no specific safety data available for the Smart Inhaler itself, but studies on asthma medications in children highlight the importance of monitoring for adverse reactions, which can be serious but are often rare. ^{1 2 6 7 8}

How is the Smart Inhaler treatment different from other asthma treatments for children?

The Smart Inhaler is unique because it provides immediate feedback on how well children are using their inhalers, helping them improve their technique and medication adherence. This feedback is delivered through a mobile app, which is not a feature of traditional inhalers. ^{1 3 9 10 11}

Research Team

Larry Yin, MD, MSPH

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

This trial is for adolescents with intellectual and developmental disabilities (IDD), such as Autism Spectrum Disorder, who also have asthma. It's designed to help those who may struggle with using an inhaler correctly due to their IDD.

Inclusion Criteria

My child and I understand and can follow the study's requirements.

I speak English or Spanish.

Not involved in other studies using digital inhalers

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group use smart inhalers daily for 8 weeks, while the control group receives standard asthma education

8 weeks

3 visits (in-person), each scheduled four weeks apart

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Smart Inhaler

Trial Overview The study tests if smart inhalers can help young people with IDD use their asthma medication more effectively. The smart inhaler provides guidance and feedback on technique, aiming to improve correct usage and lung function.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Uses smart inhaler daily for 8 weeks

Group II: Control Active Control 1 Intervention

Standard asthma education arm

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Findings from Research

A novel device that records inhalation patterns aims to improve asthma control in children aged 6 to 18 by providing immediate feedback on inhalation technique and adherence, potentially reducing asthma exacerbations.

The study will include 68 children with uncontrolled asthma and will assess the effectiveness of this feedback through a randomized controlled trial, measuring outcomes like lung function and asthma control scores over a total of 16 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does immediate smart feedback on therapy adherence and inhalation technique improve asthma control in children with uncontrolled asthma? A study protocol of the IMAGINE I study. Sportel, ET., Oude Wolcherink, MJ., van der Palen, J., et al.[2021]

The study involved 1306 quality control tests of an electronic monitoring device for asthma inhalers, showing a high reliability rate of 84% for pre-issue tests and 87% for return tests, although some devices had issues with under-recording.

Children using the device with reminder features reported significantly higher acceptability scores compared to those without reminders, with over 90% finding the device easy to use, indicating strong potential for improving asthma management in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic adherence monitoring device performance and patient acceptability: a randomized control trial. Chan, AHY., Stewart, AW., Harrison, J., et al.[2018]

In a retrospective study of 31 children with severe asthma, using a smart nebulizer to deliver high doses of inhaled corticosteroids significantly reduced the rate of asthma exacerbations requiring oral corticosteroids, from a median of 2 to 0.5 per year (p=0.021).

Hospital admissions also decreased significantly from a median of 1 to 0 after one year of treatment (p=0.028), indicating improved management of severe asthma, although lung function measures did not show significant improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small airways targeted treatment with smart nebulizer technology could improve severe asthma in children: a retrospective analysis. van den Bosch, WB., Kloosterman, SF., Andrinopoulou, ER., et al.[2022]

The use of a smart nebulizing device significantly improved adherence to inhaled corticosteroids (ICS) in children under 5 years old, with adherence rates of 86.67% compared to 62.86% in the conventional nebulization group after 12 weeks.

Children using the smart nebulizer experienced fewer emergency visits and lower rates of respiratory infections and antibiotic use, indicating that this technology not only enhances medication adherence but also improves overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect of a smart nebulizing device on adherence to inhaled corticosteroid therapy in Asthma Predictive Index-positive wheezing children. Zhou, Y., Lu, Y., Zhu, H., et al.[2022]

This scoping review aims to explore how smart devices can be used to improve asthma management in children and young adults, particularly focusing on low-income and culturally diverse populations who face higher asthma-related health challenges.

The review will analyze a wide range of studies involving participants aged 0 to 26 with asthma, using multiple databases to ensure comprehensive coverage of existing literature and to identify potential gaps in research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smart devices for the management of pediatric asthma: a scoping review protocol. Betz, CL., Lewinter, K., Kysh, L., et al.[2020]

A comprehensive analysis of 372,345 spontaneous reports from 2011 to 2017 identified 385 different safety signals related to asthma medications in children, with a notable focus on psychiatric events, highlighting the importance of monitoring these drugs in the pediatric population.

The study uncovered new safety signals, such as herpes viral infections linked to omalizumab and hypertrichosis associated with budesonide, emphasizing that age stratification is crucial for detecting unique risks in children that may not be evident in the broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. Baan, EJ., de Smet, VA., Hoeve, CE., et al.[2021]

A review of 326 spontaneous adverse drug reaction reports for asthma medications in children revealed that approximately 85% of these reports were serious, including six fatal cases, highlighting significant safety concerns.

The most commonly reported adverse reactions were psychiatric disorders (13%), respiratory issues (10%), and skin disorders (9%), with budesonide, salbutamol, and fluticasone being the medications with the highest number of reported ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011. Aagaard, L., Hansen, EH.[2021]

A systematic review of 46 studies on pediatric asthma medications revealed that inhaled corticosteroids (ICS) are associated with 174 adverse drug events (ADE), including potential issues like adrenal and growth suppression.

Serious adverse drug events were rare, occurring in 0.9-6% of cases, and there were no confirmed deaths in pediatric patients, although methodological concerns were noted regarding the identification and assessment of ADE in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of adverse drug events associated with administration of common asthma medications in children. Leung, JS., Johnson, DW., Sperou, AJ., et al.[2022]

Inhalation therapy for childhood asthma is both safe and effective, offering benefits such as low doses, rapid effects, and a wide therapeutic range.

Optimal asthma treatment in children can be achieved with the right selection of inhalation devices and consistent practical instructions for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Inhalation therapy in children with asthma]. de Jongste, JC., van Essen-Zandvliet, EE., Brackel, HJ., et al.[2008]

The Funhaler, a new small volume spacer device, significantly improved the success rate of administering asthma medication to children, with 22 out of 30 parents reporting consistent success compared to only 3 out of 30 with their existing device.

Parents and children showed better adherence and a more positive attitude towards asthma treatment when using the Funhaler, indicating its potential to enhance compliance and satisfaction in managing asthma in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new asthma spacer device to improve compliance in children: a pilot study. Chaney, G., Clements, B., Landau, L., et al.[2006]

The Single Inhaler Therapy (SIT) or Symbicort Maintenance and Reliever Therapy (SMART) approach has shown safety and efficacy in adults with asthma, and preliminary cases suggest it may also benefit children and adolescents, with two out of three cases demonstrating clear clinical improvement.

While SIT could help reduce compliance issues in managing asthma among younger patients, further studies are necessary to confirm its effectiveness and safety across different asthma phenotypes in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Formoterol-budesonide combination for maintenance and relief in children and adolescents with asthma]. de Bilderling, G., Smal, D., Bradatan, E.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Does immediate smart feedback on therapy adherence and inhalation technique improve asthma control in children with uncontrolled asthma? A study protocol of the IMAGINE I study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Electronic adherence monitoring device performance and patient acceptability: a randomized control trial. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Small airways targeted treatment with smart nebulizer technology could improve severe asthma in children: a retrospective analysis. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Short-term effect of a smart nebulizing device on adherence to inhaled corticosteroid therapy in Asthma Predictive Index-positive wheezing children. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Smart devices for the management of pediatric asthma: a scoping review protocol. [2020]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A systematic review of adverse drug events associated with administration of common asthma medications in children. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

[Inhalation therapy in children with asthma]. [2008]

10. Australia pubmed.ncbi.nlm.nih.gov

A new asthma spacer device to improve compliance in children: a pilot study. [2006]

11. Belgium pubmed.ncbi.nlm.nih.gov

[Formoterol-budesonide combination for maintenance and relief in children and adolescents with asthma]. [2018]