Digital Inhaler Use in Obstructive Lung Disease Care

NCT07214337 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00004080
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to evaluate the role digital inhaler technology on patients with obstructive lung disease in preventing admissions and exacerbation, as well as improving symptom control. The primary objective is to evaluate feasibility of study protocol, patient recruitment, and patient retention with goal recruitment of 20 participants, 60% recruitment success, and 60% retention rate for 6 months duration. The secondary objectives are the evaluation of patient admission rate, exacerbation rates, and symptoms control with use of digital inhaler technology The subject population will be patients with physician diagnosed obstructive lung disease.

Conditions

Chronic Obstructive Airways Disease Exacerbated; Chronic Obstructive Airway Disease

Keywords

Chronic Obstructive Airways Disease; COPD; COPD Exacerbation; Severe COPD; Moderate COPD; Severe Chronic Obstructive Airways Disease; Moderate Chronic Obstructive Airways Disease

Outcome Measures

Primary Outcomes (2)

• Participant Recruitment Percentage

  The investigators will be looking at what percentage of patients approached for recruitment choose to participate in the study. Accrual rate will be computed as the proportion of subjects enrolled as a function of the number of subjects screened.

  6 months

• Participant Retention Percentage

  The investigators will also be looking at what percentage patient who choose to participate remain participating for the full 6-month duration of the study period. The retention rate over the full 6-month period of follow-up will be computed among enrolled subjects.

  6 months

Secondary Outcomes (4)

• Re-admission Rate

  6 months

• COPD Exacerbation Rates

  6 months

• Symptom Control

  6 months

• Satisfaction with Device Assessed with Questionnaire

  6 months

Study Arms (1)

Digital Inhaler Attachment for Regular Care

OTHER

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

Device: Digital Inhaler Attachment

Interventions

Digital Inhaler Attachment DEVICE

This intervention is the attachment of a digital device to provide patient with coaching for optimal inhaler use and technique, as well as monitoring of patient use of inhaler to patient and health care team. Patient will continue to use inhalers prescribed as per usual care for management of COPD.

Digital Inhaler Attachment for Regular Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any sex
• Over the age of 18 years.
• Physician-diagnosed obstructive lung disease
• Speak, read, and understand English.
• The current study is a feasibility pilot. Based on the results of the study, future studies will include non-English speakers as well.
• Able to understand study requirements and comply with study procedures.
• Ability to operate a smartphone or tablet (for questionnaire and symptoms input).
• Patients who use either a DPI or an MDI device as controller medications. Medications will not be changed by the study team.

You may not qualify if:

• 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.
• Inability or unwillingness of the participant to give written informed consent.
• Pregnant women (due to complicated physiology)
• The current study is a feasibility pilot. Based on the results of the study, future studies will likely include pregnant patients as well.
• Prisoners

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Breathe California, Los Angeles County: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Links

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara Ghandehari, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinita Kusupati, MD

CONTACT

14016512622; vinita.kusupati@cshs.org

Sara Ghandehari, MD

CONTACT

sara.ghandehari@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Division of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 9, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)