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)

Conditions

• COPD Exacerbation

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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
  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.

Study Details

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.

Key Dates

First listed

Jul 23, 2026

Start date

Sep 1, 2026

Status verified

Jun 2026

Primary completion

Sep 1, 2028

Completion

Sep 1, 2028

Study Design

Enrollment

280 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
  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.
• Active Comparator: Group2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin)
  Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.

Primary Outcome Measure

Difference in Modified Borg Dyspnea Scale scores between groups [ Time Frame: From enrollment through Day 7 (end of treatment) ]

Locations (1)

Find similar trials in Knoxville, TN

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