Could a Once-a-Day inhaler replace frequent treatments for COPD emergencies?
NCT ID NCT04655170
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial is testing whether giving long-acting bronchodilators (formoterol and revefenacin) to patients hospitalized with a COPD flare-up can improve breathing as well as or better than the standard short-acting medications (albuterol and ipratropium). The study will compare the two approaches in about 60 adults aged 40 and older who are admitted with a COPD exacerbation. The goal is to see if the long-acting option is feasible, safe, and effective in this setting, potentially simplifying treatment and improving symptom control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Long-acting bronchodilators (formoterol and revefenacin) compared with short-acting bronchodilators (albuterol and ipratropium)
- What this could lead to
- If effective, this could lead to a more convenient and effective treatment for COPD flare-ups in the hospital, potentially reducing the number of doses needed and improving patient comfort.
- What could go wrong
- This is a small, early-stage trial (60 patients) that may not show a clear benefit. Long-acting bronchodilators may not be as effective or safe as the standard short-acting drugs in acute hospital settings.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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60 people
The number who actually took part.
- Started
-
Dec 2020
- Finished
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Jun 2023
- 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
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40 years and older
- Sex
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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 Hide 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. Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD 5. Able to understand and comply with study procedures 6. 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, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support 5. 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) 6. Patients with a current diagnosis of lung cancer requiring treatment 7. Patients that test positive for COVID-19 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 breast feeding
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Tennessee Medical Center
Knoxville, Tennessee, 37920-6999, United States
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