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)

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Tennessee Graduate School of Medicine

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

280 Participants
are divided into 2 treatment groups

Sponsors and collaborators