Long-Acting vs Short-Acting Bronchodilators for COPD
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for adults aged 40 or older who come to the emergency department with a COPD flare-up and need hospitalization. Participants must have a history of COPD, be able to give consent, and not have certain other lung diseases, severe heart problems, significant urinary retention or glaucoma, or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either nebulized Formoterol and Revefenacin or Albuterol and Ipratropium for up to 7 days or until hospital discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Albuterol sulfate
- Formoterol fumarate
- Ipratropium Bromide
- Revefenacin
Trial Overview
The study compares two inhaled treatments for sudden COPD worsening: one group gets long-acting bronchodilators (Formoterol twice daily plus Revefenacin once daily), while the other receives standard short-acting bronchodilators (Albuterol and Ipratropium four times daily). Patients are randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive Revefenacin 175 µg once daily and Formoterol 20 µg twice daily via a jet nebulizer for up to 7 days or until hospital discharge (if discharge occurs before Day 7). Participants will also receive placebo (sterile normal saline) to maintain blinding and mask the difference in dosing frequency compared with the comparator arm.
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Tennessee Graduate School of Medicine
Lead Sponsor
Viatris Inc.
Industry Sponsor
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