Chronic Obstructive Airways Disease ExacerbatedNCT07214337
Digital Inhaler Use in Obstructive Lung Disease Care
A study testing Digital Inhaler Attachment in people with Chronic Obstructive Airways Disease Exacerbated and Chronic Obstructive Airway Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Airways Disease Exacerbated, Chronic Obstructive Airway Disease
- What is being tested?
- Digital Inhaler Attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sara Ghandehari, MD contact
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Vinita Kusupati, 4016512622, vinita.kusupati@cshs.org
Vinita Kusupati, MD
About this study
Official title: Feasibility, Adoption and Efficacy of Digital Inhaler in the Management of Obstructive Lung Disease
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.
- Being tested
- Digital Inhaler Attachment
- Keywords
- Chronic Obstructive Airways Disease, COPD, COPD Exacerbation, Severe COPD, Moderate COPD, Severe Chronic Obstructive Airways Disease, Moderate Chronic Obstructive Airways Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Inhaler AttachmentDevice
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 group | Role | What they receive |
|---|---|---|
| Digital Inhaler Attachment for Regular Care | Other | This group of patients will be provided interactive device that provides inhaler coaching for to use for 6 month duration. Receives: Device: Digital Inhaler Attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (4)
Re-admission Rate
Hospital re-admission rate for COPD exacerbation during study period
Measured: 6 months
COPD Exacerbation Rates
Rates of COPD exacerbation after intervention during study period
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Airways Disease ExacerbatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breathe California, Los Angeles County
- Responsible party
- Principal investigator, Sara Ghandehari, Cedars-Sinai Medical Center
- Investigators
- Sara Ghandehari, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214337
- Sponsor's protocol ID
- STUDY00004080
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Adoption and Efficacy of Digital Inhaler in the Management of Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT07214337
- Acronym / sponsor ID
- STUDY00004080
- Keywords
- Chronic Obstructive Airways Disease, COPD, COPD Exacerbation, Severe COPD, Moderate COPD, Severe Chronic Obstructive Airways Disease, Moderate Chronic Obstructive Airways Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Breathe California, Los Angeles County
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Inhaler Attachment for Regular Care | Other | Device: Digital Inhaler AttachmentThis group of patients will be provided interactive device that provides inhaler coaching for to use for 6 month duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Inhaler AttachmentThis 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. | Device | Digital Inhaler Attachment for Regular Care |
Primary outcome
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Ghandehari, MD contact
Sara Ghandehari, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Inhaler Attachment in people with Chronic Obstructive Airways Disease Exacerbated and Chronic Obstructive Airway Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinita Kusupati, MD (14016512622, vinita.kusupati@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment Percentage (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.