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NCT Number: NCT07214337

Digital Inhaler Use in Obstructive Lung Disease Care

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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Key information

Conditions

Chronic Obstructive Airways Disease Exacerbated Chronic Disease Chronic Obstructive Airway Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location contact

Sara Ghandehari, MD

PRINCIPAL_INVESTIGATOR

Vinita Kusupati

CONTACT

[email protected]

4016512622

Vinita Kusupati, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Participant Recruitment Percentage

    Time frame: 6 months

    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.

  2. Participant Retention Percentage

    Time frame: 6 months

    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.

Secondary outcomes

  1. Re-admission Rate

    Time frame: 6 months

    Hospital re-admission rate for COPD exacerbation during study period

  2. COPD Exacerbation Rates

    Time frame: 6 months

    Rates of COPD exacerbation after intervention during study period

  3. Symptom Control

    Time frame: 6 months

    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.

  4. Satisfaction with Device Assessed with Questionnaire

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Ghandehari, MD

CONTACT

[email protected]

Vinita Kusupati, MD

CONTACT

[email protected]

14016512622

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • Breathe California, Los Angeles County

Registry information

Official study title

Feasibility, Adoption and Efficacy of Digital Inhaler in the Management of Obstructive Lung Disease

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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