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Could a Once-Daily inhaler replace four daily doses for COPD attacks?

NCT ID NCT07721922

Disease control Sponsor: University of Tennessee Graduate School of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This trial compares two long-acting bronchodilators (formoterol and revefenacin) against the standard short-acting combination (albuterol and ipratropium) for people hospitalized with a COPD flare-up. The goal is to see whether the longer-acting drugs can relieve shortness of breath just as well with fewer daily doses. About 280 adults aged 40 and older with COPD will take part, and their breathing difficulty will be tracked using a standard scale.

What this could mean

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

Active substance
a combination of two long-acting bronchodilators: formoterol and revefenacin
What this could lead to
If it works, this could simplify treatment for COPD flare-ups by requiring fewer doses per day while providing similar symptom relief.
What could go wrong
This is a phase 4 trial testing a non-inferiority hypothesis, so even if the new regimen matches standard care, it may not offer a clear advantage. The study is also limited to hospitalized patients, so results may not apply to milder cases.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 280 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 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: 1. Male or Female 2. Any Race 3. ≥ 40 years of age 4. History of COPD based on EMR or confirmed verbally by the patient 5. Presenting to the ED with a primary diagnosis of ECOPD or acute respiratory failure with a secondary diagnosis of COPD 6. Able to understand and comply with study procedures 7. Willingness to sign and date an Informed Consent Form Exclusion Criteria: 1. Patients unable or unwilling to sign an informed consent or cooperate with study procedures 2. Patients who are hypersensitive to Formoterol or Revefenacin 3. Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway 4. Patients who have previously participated in the study 5. Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support based on: i. Inability to maintain respiratory effort ii. Cyanosis iii. Hemodynamic instability iv. Deterioration in mental status 6. Patients who, per the investigator, have unstable cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, recent MI (within 12 weeks), ventricular arrhythmia, or decompensated heart failure) 7. Patients with a current diagnosis of lung cancer requiring treatment 8. Pulmonary diseases other than COPD, or lobar pneumonia 9. Patients with acute psychiatric illness deemed significant by the investigator 10. Patients with a history of glaucoma deemed significant by the investigator 11. History of urinary retention deemed significant by the investigator 12. Women who are pregnant or breastfeeding

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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.

COPD exacerbation

How to take part

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

  1. The places running it

    1 site. 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

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

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