Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07721922

Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)

The primary aim is to determine whether nebulized Formoterol twice daily plus Revefenacin once daily is non-inferior to standard-of-care nebulized Albuterol and Ipratropium therapy four times daily in relieving dyspnea among patients with ECOPD presenting to the ED and requiring hospitalization, as measured by the Modified Borg Dyspnea Scale.

The hypothesize is that patients in the ED for ECOPD, improvement in symptoms, safety, and length of ED or hospital stay after treatment with nebulized Revefenacin and Formoterol will be non-inferior to the Albuterol and Ipratropium combination. The long-acting bronchodilator regimen will provide comparable symptom control with fewer total drug doses compared with standard treatment with short-acting bronchodilators, namely, nebulized Albuterol and Ipratropium. To the best of our knowledge, this will be the first prospective, randomized, double-blind investigation to compare a combination of long-acting nebulized LAMA/LABA bronchodilators with a standard-of-care combination of short-acting nebulized SAMA/SABA bronchodilators in patients with an ECOPD in the ED/hospital setting.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location contact

Jennifer Ferris, MSHS

CONTACT

[email protected]

865-305-7975

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female
  • Any Race
  • ≥ 40 years of age
  • History of COPD based on EMR or confirmed verbally by the patient
  • Presenting to the ED with a primary diagnosis of ECOPD or acute respiratory failure with a secondary diagnosis of COPD
  • Able to understand and comply with study procedures
  • Willingness to sign and date an Informed Consent Form

Exclusion criteria

  • Patients unable or unwilling to sign an informed consent or cooperate with study procedures
  • Patients who are hypersensitive to Formoterol or Revefenacin
  • Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway
  • Patients who have previously participated in the study
  • 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

  • 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)
  • Patients with a current diagnosis of lung cancer requiring treatment
  • Pulmonary diseases other than COPD, or lobar pneumonia
  • Patients with acute psychiatric illness deemed significant by the investigator
  • Patients with a history of glaucoma deemed significant by the investigator
  • History of urinary retention deemed significant by the investigator
  • Women who are pregnant or breastfeeding

Treatment and study plan

Revefenacin

Drug

Revefenacin 175 µg in 3 mL inhalation solution administered once daily in the morning via oral inhalation using a jet nebulizer.

Other names: YUPELRI

formoterol fumarate

Drug

Formoterol fumarate 20 μg in 2 mL inhalation solution administered twice daily in the morning and evening via oral inhalation using a jet nebulizer.

Other names: Perforomist

Placebo (sterile normal saline)

Other

Twice daily (sterile normal saline 3 ml) to maintain blinding and mask the difference in dosing frequency compared with the comparator arm.

Albuterol sulfate

Drug

Albuterol sulfate 2.5 mg in 3 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.

Other names: Ventolin

ipratropium bromide

Drug

Ipratropium Bromide 500 μg in 2.5 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.

Other names: Atrovent

Primary outcomes

  1. Difference in Modified Borg Dyspnea Scale scores between groups

    Time frame: From enrollment through Day 7 (end of treatment)

    This is a scale asks the subject to rate the difficulty of their breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal. This will be recorded prior to dosing twice a day between 7 and 9 am & pm. Scores from Group 1 and Group 2 will be averaged and compared.

Secondary outcomes

  1. Number of patients discharged home from the ED

    Time frame: From enrollment through Day 7 (end of treatment)

  2. Number of patients admitted to a hospital floor or require ED observation for >24 hours (in-hospital patients)

    Time frame: From enrollment through Day 7 (end of treatment)

  3. Length of hospital or ED stay

    Time frame: From enrollment through Day 7 (end of treatment)

  4. Number of Participants with the Need to Switch Therapy

    Time frame: From enrollment through Day 7 (end of treatment)

  5. Total number of bronchodilator doses per hospital or ED stay

    Time frame: From enrollment through Day 7 (end of treatment)

  6. Total number of rescue doses used

    Time frame: From enrollment through Day 7 (end of treatment)

  7. Number of Participants with Failure of Treatment (Need for Mechanical Ventilation or Death

    Time frame: From enrollment through Day 7 (end of treatment)

    Failure of treatment will be defined as any of the following: death, the need for a patient to receive mechanical ventilation, or the need for a patient to discontinue long-acting bronchodilators during the trial. The need for rescue medications while maintaining the assigned treatment will not be considered a failure of treatment.

  8. Number of Participants Requiring Supplemental Oxygen

    Time frame: From enrollment through Day 7 (end of treatment)

  9. Differences in FEV1/FVC values between enrollment and discharge/end of study.

    Time frame: From enrollment through Day 7 (end of treatment)

    Bedside spirometry will be performed by respiratory therapists with the patient in a sitting position using a handheld portable spirometer. The patient will be asked to make a tight seal around the mouthpiece with their lips and forcefully exhale after a deep inhalation. The patient will be instructed to continue forceful and rapid exhalation until no more air is expelled from their lungs. The best of 3 efforts will be used for analysis. FEV1/FVC<0.7 will be used to diagnose airflow obstruction.

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Collaborators

  • Viatris Inc.

Registry information

Official study title

Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD): A Phase IV, Prospective, Randomized, Blinded, Parallel-group Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.