Inhaler Trainer for Asthma and COPD

Overseen By Leah Traeger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Koronis Biomedical Technologies

Must be taking: DPI inhalers

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how effectively an Inhaler Trainer System aids individuals with asthma or COPD (a lung disease that makes breathing difficult) in improving their inhaler use. The study compares this new device, which provides real-time feedback on inhaler technique, with traditional brief instructions. Participants must have asthma or COPD, use specific inhalers like Spiriva or Serevent, and have no prior experience with a special device for inhaler training. The goal is to determine if the device can simplify correct inhaler use and improve breathing. As an unphased trial, this study allows participants to contribute to innovative research that could enhance inhaler use for many.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your prescribed inhalers, as the study involves training on inhaler use.

What prior data suggests that the Inhaler Trainer Device is safe for inhaler skill training?

Earlier research has examined digital inhalers, such as the Inhaler Trainer System, for asthma and COPD in over 20 studies. These studies found that these devices can help patients take their medication more regularly and reduce the risk of flare-ups. Importantly, no serious safety issues were reported with using digital inhalers. The main goal was to help patients use their inhalers correctly, which is key to managing asthma and COPD effectively. Based on past research, the Inhaler Trainer System appears to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Inhaler Trainer System because it offers a new way to help patients with asthma and COPD improve their inhaler technique. Unlike traditional methods that rely on verbal instructions, this device actively monitors the user's inhalation and provides real-time feedback. This ensures that patients are using their inhalers correctly, which can lead to better delivery of medication to the lungs and potentially improve treatment outcomes. By focusing on technique optimization, this system could significantly enhance the effectiveness of existing inhaler medications.

What evidence suggests that the Inhaler Trainer Device is effective for asthma and COPD?

Research has shown that correct inhaler use can greatly benefit people with asthma and COPD. For example, one study found that when asthma patients improved their inhaler technique, they gained better control over their asthma, with many reaching a well-managed state. Another study demonstrated that correcting poor inhaler use in COPD patients led to better lung function, as evidenced by improved breathing tests. This trial will compare two approaches: the Inhaler Trainer Device, which provides real-time feedback on inhaler technique, and Brief Interventions (BI), which involve verbal and written instructions on proper inhaler use. Additionally, evidence suggests that personalized inhaler training can reduce mistakes in inhaler use. Overall, proper inhaler use is key to enhancing treatment effectiveness for these conditions. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with a physician's diagnosis of COPD or asthma who are inexperienced with inhaler trainer devices. Participants must have used specific inhalers like Serevent Diskus, Incruse Ellipta, Spiriva Handihaler, or Tudorza Pressair.

Inclusion Criteria

I have never been trained to use an inhaler with a tool other than the inhaler itself and a spacer.

I am between 18 and 85 years old.

I have been diagnosed with COPD or asthma by a doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment and Education

Participants complete assessments, including a lung function test via spirometry, and receive inhaler education via either the Inhaler Trainer Device learning program or standard education techniques.

1 day

1 visit (in-person)

Treatment

Participants use their inhaled medications with the inhaler trainer device for 6 weeks post-baseline.

6 weeks

1 visit (in-person) at 6 weeks

Follow-up

Participants return for an in-person evaluation of their inhaler skills, lung function, and acute care utilization. A post-study semi-structured interview is conducted to gather feedback on the device.

1 day

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Inhaler Trainer System

Trial Overview The study tests the Inhaler Trainer Device against standard brief intervention to see which helps patients use their inhalers better. It involves initial assessments, lung function tests, and follow-up evaluations at 6 weeks to measure effectiveness.

How Is the Trial Designed?

Group I: Inhaler Trainer Device Experimental Treatment 3 Interventions

The Inhaler Trainer Device will monitor patients' inspiratory waveform to confirm technique compliance based on objective metrics and provide feedback on how to better perform technique. This intervention utilizes an instrumented training inhaler capable of accurately measuring the real-time inspiratory airflow achieved by the user when they perform their inhale maneuver. If a user's inspiratory flow fails to produce an inspiratory waveform with sufficient airflow parameters, the inhaler device may not optimally aerosolize the medication, and the delivered dosage to the lung will be negatively affected. The device measures the most important flow parameters in the users' real-time inspiration performance and translates them into an estimation of the dose delivered to the lung, based on detailed characterization of the user's inhaler product.

Group II: Brief Interventions (BI) Active Control 2 Interventions

During inpatient admission, participants randomized to the BI condition will receive the following: First, they will undergo an initial assessment of their respiratory inhaler technique using device-specific checklists. Participants will then be given step-by-step verbal instructions and a copy of written instructions by the trained educator describing appropriate inhaler technique for their respiratory inhalers. The educator will not demonstrate the appropriate use of each inhaler to the patient, though the educator will be free to answer questions about appropriate use if posed by the study subject.

Who Is Running the Clinical Trial?

Koronis Biomedical Technologies

Lead Sponsor

Trials

4

Recruited

200+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8748930/

Effectiveness of individualized inhaler technique training ... In contrast, asthma patients displayed a better skill level in the use of the inhalers. 52.9% asthma patients had DeIT vs 68.6% in COPD patients ...

2. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-021-01627-y

a prospective clinical study | BMC Pulmonary Medicine A recent study demonstrated that correcting poor inhaler technique improves the quality of life of COPD patients, as evidenced by improved FEV1 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213219822008285

Effectiveness of a Digital Inhaler System for Patients With ... The primary outcome was improvement in asthma control, defined as achievement of well-controlled asthma (ACT score ≥ 20) and/or gaining a clinically meaningful ...

4. nature.com nature.com/articles/s41533-017-0022-1

Effectiveness and success factors of educational inhaler ... Outcomes were most frequently recorded as correct-steps (64.1%), whereas correct-patients outcome reporting was less common (33.3%). One study ...

5. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(23)00472-5/fulltext

Recognizing and Tackling Inhaler Technique Decay in ... A poor inhaler technique continues to represent a substantial barrier to effective asthma and chronic obstructive pulmonary disease ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8589868/

Digital Inhalers for Asthma or Chronic Obstructive ... More than 20 clinical studies of digital inhalers in asthma or COPD collectively show improvement in medication adherence, exacerbation risk, and patient ...

7. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(21)00464-5/fulltext

The Impact of Inhaler Device Regimen in Patients with ... Employing a single inhaler device improves clinical outcomes and reduces health care use compared with multiple-inhaler regimens for patients ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0954611117300136

Optimizing drug delivery in COPD: The role of inhaler devices A pragmatic review on the currently available inhaler devices for treating COPD. Incorrect use of inhaler devices can lead to poorly controlled disease status.

9. nature.com nature.com/articles/s41533-023-00346-7

Effective respiratory management of asthma and COPD ... This article discusses the importance of combining effective respiratory management of asthma and COPD with environmental considerations.

10. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-018-0936-3

Use and inhalation technique of inhaled medication in ... This study aims to present data on inhaler technique and its impact on quality of life (QoL) and symptom control in a typical population of patients with ...