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Not yet recruiting NCT07214337

Digital Inhaler Use in Obstructive Lung Disease Care

No phase Interventional Chronic Obstructive Airways Disease Exacerbated Chronic Obstructive Airway Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital Inhaler Attachment.
Who it may be relevant to
Registry conditions: Chronic Obstructive Airways Disease Exacerbated, Chronic Obstructive Airway Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Digital 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.

Primary outcome measures

  • Participant Recruitment Percentage [Time frame: 6 months]
  • Participant Retention Percentage [Time frame: 6 months]
Secondary outcome measures (4)
  • Re-admission Rate [Time frame: 6 months]
  • COPD Exacerbation Rates [Time frame: 6 months]
  • Symptom Control [Time frame: 6 months]
  • Satisfaction with Device Assessed with Questionnaire [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Cedars-Sinai Medical Center — Los Angeles

Identifiers

NCT: NCT07214337 · STUDY00004080

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗