COPD ExacerbationSHORENCT06544928
Study on Home Obstructive Respiratory Exacerbations
An observational study of COPD Exacerbation and COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, run by Strados Labs, Inc. at 1 site in United States.
Trial summary
Strados Labs has developed the Strados™ Respiratory Care Platform, including the RESP™ Biosensor System, which encompasses a clinically validated wearable, non-invasive, Bluetooth-enabled device capable of remotely collecting respiratory data. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD Exacerbation, COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, COPD Exacerbation Acute
- What is being tested?
- RESP™ Biosensor
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to 31 Mar 2027
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are hospitalized for COPD exacerbation with plan for discharge within 48 hoursare, OR are visiting their pulmonologist in the outpatient setting or via telehealth within 14 days of a COPD exacerbation with inpatient stay.
Who may be able to join
- 1. Males and females between the ages of 40 and 80 with documented physician-diagnosed COPD and FEV1/FVC<0.70 or LLN based on post-bronchodilator spirometry
- Hospitalized for COPD exacerbation with plan for discharge within 48 hours OR
- Visiting pulmonologist post COPD-exacerbation within 14 days of discharge from hospital 3. Tobacco History: Current or Former Smoker
- Has smoked at least 100 cigarettes in his/her lifetime 4. Patient can follow study procedures, including instructions for self-placement and operation of biosensor
- Patient has experience/owns a smartphone 5. Patient is accessible by telehealth/telephone for duration of the study 6. Patient is able and willing to return to study site for study visits as necessary
Who cannot join
- Patient is unable or unwilling to provide informed consent
- Any condition that, in the opinion of the investigator, would limit the patient's activity in the study and/or adequate lung sound capture using the RESP™ wearable device
- Patient with end-stage medical condition with expected survival no more than 6 months
- History of adverse reaction or allergy to adhesives such as TegaDerm®
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Jefferson Einstein Philadelphia Hospital
Philadelphia, Pennsylvania, 19141
About this study
Official title: Utility of Remote Lung Auscultation in COPD With RESP™ Biosensor
Strados Labs has developed the Strados™ Respiratory Care Platform, including the RESP™ Biosensor System, which encompasses a clinically validated wearable, non-invasive, Bluetooth-enabled device capable of remotely collecting respiratory data. RESP was designed to extend both the geographical and temporal range of lung sound recordings, which can improve the remote monitoring of high-risk COPD patients. The RESP Biosensor continuously captures lung sounds and chest wall motions that are wirelessly transmitted through a mobile app to a web application to be analyzed for changes in respiratory health.
Preliminary data suggest good patient compliance and the potential for RESP to detect early COPD exacerbation. However, uncertainty on the optimal RESP monitoring procedure and insufficient longitudinal RESP data for definitive statistical correlation with COPD exacerbations warrant further study.
We plan to conduct an observational study to assess feasibility of home RESP remote patient monitoring and secondarily collect the longitudinal data necessary to establish the correlation between RESP based measures and standard of care measures of COPD symptom severity.
- Conditions
- COPD Exacerbation, COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, COPD Exacerbation Acute, COPD
- Being tested
- RESP™ Biosensor
- Keywords
- SHORE, SL-RS-SHORE, RESP™ Biosensor, RESP™, Strados Labs
- 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.
RESP™ BiosensorDevice
For this observational study, the RESP™ Biosensor will be placed on the patient for periodic recording of auscultory sound.
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Device: RESP Biosensor The RESP Biosensor will be placed on all qualitfying subjects for recording of auscultory sound. Receives: Device: RESP™ Biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study will assess observational outcome measures. No formal efficacy or safety endpoints are defined.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start5 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Strados Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544928
- Sponsor's protocol ID
- SL-RS-SHORE
- Acronym
- SHORE
- Status last verified
- Jan 2026
- First submitted
- 5 Aug 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Remote Lung Auscultation in COPD With RESP™ Biosensor
- ClinicalTrials.gov ID
- NCT06544928
- Acronym / sponsor ID
- SHORE / SL-RS-SHORE
- Conditions
- COPD Exacerbation, COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, COPD Exacerbation Acute, COPD
- Keywords
- SHORE, SL-RS-SHORE, RESP™ Biosensor, RESP™, Strados Labs
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Strados Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Aug 2024 (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.
Strados Labs has developed the Strados™ Respiratory Care Platform, including the RESP™ Biosensor System, which encompasses a clinically validated wearable, non-invasive, Bluetooth-enabled device capable of remotely collecting respiratory data. RESP was designed to extend both the geographical and temporal range of lung sound recordings, which can improve the remote monitoring of high-risk COPD patients. The RESP Biosensor continuously captures lung sounds and chest wall motions that are wirelessly transmitted through a mobile app to a web application to be analyzed for changes in respiratory health.
Preliminary data suggest good patient compliance and the potential for RESP to detect early COPD exacerbation. However, uncertainty on the optimal RESP monitoring procedure and insufficient longitudinal RESP data for definitive statistical correlation with COPD exacerbations warrant further study.
We plan to conduct an observational study to assess feasibility of home RESP remote patient monitoring and secondarily collect the longitudinal data necessary to establish the correlation between RESP based measures and standard of care measures of COPD symptom severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | – | Device: RESP™ BiosensorDevice: RESP Biosensor The RESP Biosensor will be placed on all qualitfying subjects for recording of auscultory sound. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are hospitalized for COPD exacerbation with plan for discharge within 48 hoursare, OR are visiting their pulmonologist in the outpatient setting or via telehealth within 14 days of a COPD exacerbation with inpatient stay.
Key inclusion criteria (5 listed)
- 1. Males and females between the ages of 40 and 80 with documented physician-diagnosed COPD and FEV1/FVC<0.70 or LLN based on post-bronchodilator spirometry
- Hospitalized for COPD exacerbation with plan for discharge within 48 hours OR
- Visiting pulmonologist post COPD-exacerbation within 14 days of discharge from hospital 3. Tobacco History: Current or Former Smoker
- Has smoked at least 100 cigarettes in his/her lifetime 4. Patient can follow study procedures, including instructions for self-placement and operation of biosensor
- Patient has experience/owns a smartphone 5. Patient is accessible by telehealth/telephone for duration of the study 6. Patient is able and willing to return to study site for study visits as necessary
Key exclusion criteria (4 listed)
- Patient is unable or unwilling to provide informed consent
- Any condition that, in the opinion of the investigator, would limit the patient's activity in the study and/or adequate lung sound capture using the RESP™ wearable device
- Patient with end-stage medical condition with expected survival no more than 6 months
- History of adverse reaction or allergy to adhesives such as TegaDerm®
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 |
|---|---|---|
| RESP™ BiosensorFor this observational study, the RESP™ Biosensor will be placed on the patient for periodic recording of auscultory sound. | Device | All Subjects |
Primary outcome
The study will assess observational outcome measures. No formal efficacy or safety endpoints are defined.
Time frame: 12 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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation and COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, run by Strados Labs, Inc. 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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 20 Jan 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study will assess observational outcome measures. No formal efficacy or safety endpoints are defined. (time frame: 12 months). 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 20 Jan 2026.