Digital Inhaler Use in Obstructive Lung Disease Care

Not Applicable

Not yet recruiting

• Conditions: Chronic Obstructive Airways Disease Exacerbated; Chronic Obstructive Airway Disease

• Registration Number: NCT07214337
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-07
• Last Update Submitted: 2025-10-07
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2025-11-01
• Primary Completion: 2027-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Participant Recruitment Percentage	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.
Participant Retention Percentage	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 Outcome Measures

Name	Time	Method
Re-admission Rate	6 months	Hospital re-admission rate for COPD exacerbation during study period
COPD Exacerbation Rates	6 months	Rates of COPD exacerbation after intervention during study period
Symptom Control	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.
Satisfaction with Device Assessed with Questionnaire	6 months	Assessment of patient satisfaction with use of device utilizing questionnaire to be administered at the conclusion of the study.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States