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)

ConditionCOPD Exacerbation

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Revefenacin
Drug
Revefenacin 175 µg in 3 mL inhalation solution administered once daily in the morning via oral inhalation using a jet nebulizer.
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.
Placebo (Sterile Normal Saline)
Other intervention
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.
Ipratropium Bromide
Drug
Ipratropium Bromide 500 μg in 2.5 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.

Treatment groups

280 Participants

are divided into 2 treatment groups

Group A: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)Experimental treatment 3 interventions

Group B: Group2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin)Active comparator 2 interventions

Trial outcomes

Primary outcomes

Difference in Modified Borg Dyspnea Scale scores between groups

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.

Time frame