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Not yet recruitingNCT07214337Updated Oct 9, 2025

Digital Inhaler Use in Obstructive Lung Disease Care

An interventional study of Digital Inhaler Attachment in Chronic Obstructive Airways Disease Exacerbated and Chronic Obstructive Airway Disease, sponsored by Cedars-Sinai Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-09.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • 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
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In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

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.
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Digital Inhaler Attachment for Regular Care

    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

  • DeviceDigital Inhaler Attachment

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

Secondary outcomes

  1. Re-admission Rate

    Hospital re-admission rate for COPD exacerbation during study period

    Time frame: 6 months

  2. COPD Exacerbation Rates

    Rates of COPD exacerbation after intervention during study period

    Time frame: 6 months

  3. Symptom Control

    Overall symptoms control of COPD after intervention during study period. This will utilize the COPD Assessment Test. Scores with this test can range from 0 to 40, with higher score representing worse severity of disease and worse symptom control.

    Time frame: 6 months

  4. Satisfaction with Device Assessed with Questionnaire

    Assessment of patient satisfaction with use of device utilizing questionnaire to be administered at the conclusion of the study.

    Time frame: 6 months

07

Study locations

1 site
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
    • Vinita Kusupati · Contact · vinita.kusupati@cshs.org · 4016512622
    • Vinita Kusupati, MD · Sub investigator
    • Sara Ghandehari, MD · Principal investigator
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References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07214337
Lead sponsor
Cedars-Sinai Medical Center
Collaborators
Breathe California, Los Angeles County
Responsible party
Sara Ghandehari (Professor of Medicine, Division of Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center) — Principal investigator
First posted
Oct 9, 2025
Start date
Nov 1, 2025 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 9, 2025

Study contacts

Vinita Kusupati, MD
Contact
vinita.kusupati@cshs.org
14016512622
Sara Ghandehari, MD
Contact
sara.ghandehari@cshs.org
Sara Ghandehari, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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