Digital Inhaler for COPD

Overseen By Vinita Kusupati, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must be taking: DPI, MDI

Disqualifiers: Serious uncontrolled conditions, pregnancy, prisoners, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital inhaler device for individuals with obstructive lung disease, such as COPD, to determine if it can reduce hospital visits and improve daily breathing. The device provides coaching on effective inhaler use. Participants must have a doctor-diagnosed obstructive lung disease and be comfortable using a smartphone or tablet to update symptoms. The study will assess adherence to the device over six months and its impact on symptoms. As an unphased trial, this study presents a unique opportunity to contribute to innovative research that could enhance daily life for those with obstructive lung disease.

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

No, you don't have to stop taking your current medications. The study team will not change your medications.

What prior data suggests that this digital inhaler is safe for patients with obstructive lung disease?

Research has shown that digital inhaler attachments are generally well-tolerated by people with lung diseases like COPD. Studies have found that these devices can help patients use their inhalers correctly by providing guidance and reminders, leading to better symptom control without extra side effects.

One study found that using digital inhalers for remote monitoring and reminders did not increase negative side effects, suggesting the technology is safe for regular use. Additionally, digital inhalers have helped people adhere to their treatment plans, which can improve health outcomes.

Overall, digital inhaler attachments appear safe for people with COPD and other lung diseases. They assist patients in managing their conditions effectively without causing additional harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Inhaler Attachment for COPD because it offers an innovative approach to managing this chronic condition. Unlike traditional inhalers, this digital attachment not only dispenses medication but also provides real-time coaching to ensure proper inhaler technique, which can improve drug delivery and effectiveness. This interactive feature could lead to better symptom control and potentially reduce hospitalizations by empowering patients to manage their condition more effectively.

What evidence suggests that this digital inhaler is effective for obstructive lung disease?

Studies have shown that digital inhalers can help people with lung diseases like COPD take their medication more regularly and improve their health. In this trial, participants will use a Digital Inhaler Attachment, which provides inhaler coaching over a 6-month period. Research indicates that these inhalers remind users to take their medication, leading to better symptom control. Digital inhalers track medication use and send reminders, simplifying condition management for patients. Some studies have found that this technology can reduce flare-ups and hospital visits. While results can vary, digital inhalers show promise in enhancing treatment effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Sara Ghandehari, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with physician-diagnosed obstructive lung disease, such as COPD. It aims to recruit 20 participants and expects at least 60% success in both recruitment and retention over a six-month period.

Inclusion Criteria

My sex does not affect my eligibility.

I have been diagnosed with a lung condition that blocks airflow.

I am over 18 years old.

Exclusion Criteria

Physically disabled such that they are incapable of using digital devices or metered dose inhalers

Suffer from any visual, hearing or cognitive impairment that cannot be corrected enough to operate the devices properly. Mild/moderate vision loss and mild hearing loss may be included with appropriate corrective measures that do not affect the device usage

Suffering from serious uncontrolled medical conditions that may interfere with study conduct

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a digital inhaler attachment for regular care to manage obstructive lung disease

6 months

Regular use with periodic assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Inhaler Attachment

Trial Overview

The study is testing a digital inhaler attachment to see if it can help prevent hospital admissions and worsening of symptoms in people with obstructive lung disease. The focus is on the feasibility of the study protocol, patient recruitment, and retention.

How Is the Trial Designed?

Group I: Digital Inhaler Attachment for Regular Care Experimental Treatment 1 Intervention

This group of patients will be provided interactive device that provides inhaler coaching for to use for 6 month duration.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Breathe California, Los Angeles County

Collaborator

Trials

1

Recruited

20+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11615661/

Digital remote maintenance inhaler adherence ...

This review investigated the feasibility and impact of remote electronic inhaler adherence monitoring (EIM) and intervention platforms on clinical outcomes in ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07214337

Digital Inhaler Use in Obstructive Lung Disease Care

There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial ...

3.

journal.copdfoundation.org

journal.copdfoundation.org/jcopdf/id/1538/Use-of-a-Digital-Inhaler-to-Assess-COPD-Disease-Variability-and-Identify-Impending-Acute-COPD-Exacerbations-A-Pilot-Study

Use of a Digital Inhaler to Assess COPD Disease ...

Rationale: Studies have shown that digital inhalers, using remote monitoring data, can improve medication adherence and clinical outcomes, such ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611124000817

A comprehensive evaluation of online inhaler use ...

This study highlights gaps in online resources describing inhaler technique, particularly related to preparation/first use and post-usage/device care steps.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12334831/

The evolving landscape of digital inhaler platforms and ...

Clinical trials assessing digital inhalers for managing chronic airway disease have produced mixed results. Table 2 summarises the outcomes of ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611122003031

Integrating Digital Inhalers into Clinical Care of COPD/Asthma

Modernizing inhaled medications through digital technology can help address persistent problems of non-adherence and poor inhaler technique in patients with ...

7.

mhealth.jmir.org

mhealth.jmir.org/2025/1/e57645

Electronic Inhaler Monitoring for COPD/Asthma Patients

This study aims to systematically evaluate qualitative studies on the experiences of patients with COPD and asthma using EIMDs.

8.

bmjopenrespres.bmj.com

bmjopenrespres.bmj.com/content/12/1/e002577

Predictive ML for COPD exacerbations with digital inhaler

Our findings show that data from a digital reliever inhaler can be used to build a model predictive of near-term acute COPD exacerbations.