Smart Inhaler for Childhood Asthma

(IDD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Larry Yin, MD, MSPH

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital Los Angeles

Must be taking: Inhaled corticosteroids

Disqualifiers: Limited life expectancy, others

No Placebo Group

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

Trial 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 (Corticosteroid)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Hospital Los Angeles Los Angeles, CA

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Patients Recruited

5,075,000+

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] Many asthmatic children suffer from uncontrolled asthma with frequent exacerbations, despite an optimal treatment plan using inhalation medication. Studies have shown that therapy adherence and inhalation technique are often suboptimal in asthmatic children, but these have traditionally been hard to measure. A novel device functioning as an add-on to the inhaler has been developed to measure both aspects by recording vibration patterns during inhalation. This data can be converted to smart feedback and provided to patients immediately via a mobile application. The aim of this study is to improve asthma control in children between 6 and 18 years old by providing immediate smart feedback on the intake of inhalation medication. Asthma control will be measured by forced expiratory volume in 1 s, (Childhood) Asthma Control Test ((c-)ACT) score, and lung function variability and reversibility.

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

Electronic adherence monitoring device performance and patient acceptability: a randomized control trial. [2018] To investigate the performance and patient acceptability of an inhaler electronic monitoring device in a real-world childhood asthma population.

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] Conventional inhaler devices have a low efficacy in targeting small airways. Smart nebulizers can be used to increase deposition to small airways by adjusting the flow and depth of each inhalation based on patients 'individual inspiratory capacity. We investigated whether targeting of high dose inhaled corticosteroids (ICS) to small airways with a smart nebulizer could reduce exacerbation rate in children with severe asthma (SA).

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] To explore the effect of a smart nebulizing device on the rate of adherence to inhaled corticosteroid (ICS) in children with positive Asthma Predictive Index.

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

Smart devices for the management of pediatric asthma: a scoping review protocol. [2020] The objective of this scoping review is to identify the scope of literature published on the use of smart devices for interventions in pediatric asthma, including low income and culturally diverse populations.

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] As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals.

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

Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011. [2021] Information about safety issues from use of asthma medications in children is limited. Spontaneous adverse drug reaction (ADR) reports can provide information about serious and rarely occurring ADRs in children.

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] To systematically review the literature and determine frequencies of adverse drug events (ADE) associated with pediatric asthma medications.

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

[Inhalation therapy in children with asthma]. [2008] Inhalation therapy for childhood asthma is safe and effective. It has the advantages of a low dose, a rapid effect and a wide therapeutic range. For the majority of children the available medications make it possible now to treat asthma optimally, provided that special care is taken to select the appropriate inhalation devices, and repeated practical instructions are given.

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

A new asthma spacer device to improve compliance in children: a pilot study. [2006] This pilot study was designed to compare the acceptance, ease of use, and effects on compliance between currently used spacer devices and the Funhaler--a new small volume spacer device designed to improve adherence to asthma medication in children.

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

[Formoterol-budesonide combination for maintenance and relief in children and adolescents with asthma]. [2018] International guidelines have been edited to standardize asthma management. These guidelines are often difficult to translate to clinical practice because of gaps in the knowledge of clinical practitioners but also because of compliance issues, particularly in children and adolescents. A new approach named SIT (for Single Inhaler Therapy) or SMART (for Symbicort Maintenance and Reliever Therapy) has demonstrated its safety and efficacy in numerous studies of adults with asthma summarized in two Cochrane reviews. We present here three clinical cases from our clinic where this approach was applied to children and adolescents with a clear clinical and functional response for two of them. We suggest that the SIT regimen can be used in some children and adolescents with asthma and has the potential to reduce compliance issues. Moreover asthma phenotypes have been described and it is possible that only some of these phenotypes respond to this regimen. However to confirm the efficacy and safety of the SIT regimen in children and adolescents more studies are needed.