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Could a simple patch replace daily spirometry for COPD patients?

NCT ID NCT07430605

Knowledge-focused Sponsor: LASARRUS Clinic and Research Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a wearable patch called WearME-Pro that tracks lung function in people with COPD during daily life. Over 10 months, 82 adults will use the patch at home and compare its readings to a standard handheld spirometer. The goal is to see if the patch is accurate, easy to use, and reliable for remote monitoring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
WearME-Pro Patch System (wearable device)
What this could lead to
If successful, this could provide a convenient way for people with COPD to monitor their lung function at home without frequent clinic visits.
What could go wrong
This is an early-stage study with only 82 participants, and the patch readings are investigational—not yet proven to replace standard spirometry. The device may be less accurate or harder to use than expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 82 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 21 years or older, either sex. * Diagnosed with COPD per GOLD criteria (GOLD 2025): post-bronchodilator FEV1/FVC \< 0.70; stratified by post-bronchodilator FEV1% predicted (severity strata). * On stable maintenance therapy for at least 2 months (no COPD medication class changes or dose escalations). * Current, former, or never smoker (smoking history collected but not an eligibility requirement). * Able to perform activities of daily living and complete study procedures (e.g., sit upright and perform spirometry maneuvers). * Able and willing to provide informed consent. * Not currently enrolled in another investigational device study that could confound outcomes (prior WearME-Basic Phase I participation permitted if completed and not concurrent). * Owns a compatible smartphone/tablet or willing to use a loaner device. * Willing to wear WearME-Pro patch and perform daily handheld spirometry throughout the study. * Optional subset only: willing to wear Cardea SOLO ECG patch for up to 24-48 hours at baseline and end of study if selected. Exclusion Criteria: * COPD exacerbation within past 6 weeks requiring systemic corticosteroids and/or antibiotics, urgent/ED visit, or hospitalization. * Known allergy or severe skin sensitivity to medical adhesives, or dermatologic conditions at intended placement sites. * Any condition that, in the investigator's opinion, may interfere with compliance or safety. * Inability or unwillingness to perform daily spirometry or to use the mobile app.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease (COPD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins

    Baltimore, Maryland, 21224, United States

  • LASARRUS Clinic and Research Center Inc.

    Baltimore, Maryland, 21230, United States

  • TidalHealth

    Salisbury, Maryland, 21801, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.