What this study is
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.
What's being tested
- Digital Inhaler Attachment
Intervention · 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.
Study details
- Official title
- Feasibility, Adoption and Efficacy of Digital Inhaler in the Management of Obstructive Lung Disease
- Sponsor
- Cedars-Sinai Medical Center
- Conditions
- Chronic Obstructive Airways Disease Exacerbated · Chronic Obstructive Airway Disease
- Enrolling
- 20 people
- Starts
- 2025-11-01
- Est. completion
- 2027-06
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCedars-Sinai Medical Center
Los Angeles, California, United States
- Vinita Kusupati · Contact4016512622vinita.kusupati@cshs.org
- Vinita Kusupati, MD · Sub-investigator
- Sara Ghandehari, MD · Principal investigator
Study team
Sponsor
Cedars-Sinai Medical Center
Study ID STUDY00004080
Principal investigator
Sara Ghandehari, MD
Cedars-Sinai Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.