About this trial
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.
Eligibility criteria
Qualifiers
Male or Female
Any Race
≥ 40 years of age
History of COPD based on EMR or confirmed verbally by the patient
Disqualifiers
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
Trial design
Treatments tested in this trial
- Revefenacin
- formoterol fumarate
- Placebo (Sterile Normal Saline)
- Albuterol sulfate
- Ipratropium Bromide
Treatment groups
Sponsors and collaborators
University of Tennessee Graduate School of Medicine
Lead sponsor
Viatris Inc.
Collaborator