Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD

NCT04655170 | Completed Phase 4 Results FDA Drug

• 1 other identifier: UTGSM 4586
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the feasibility, safety and efficacy of a combination of nebulized Formoterol and Revefenacin among patients hospitalized for AECOPD compared with standard-of-care therapy with nebulized Albuterol and Ipratropium.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• Difference in Modified Borg Dyspnea Scale Scores Between Groups

  The Modified Borg Dyspnea 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 scale was recorded prior to dosing twice a day between 7 and 9 am \& pm.

  From enrollment to the end of treatment at Day 7

Secondary Outcomes (6)

• Total Visits for Study Drug Administration Per Day Received by Each Patient

  From enrollment to the end of treatment at Day 7

• Total Doses of Bronchodilators Per Hospital Stay

  From enrollment to the end of treatment at Day 7

• Total Number of Rescue Doses Administered During the Hospital Stay in Patients With Exacerbations of COPD

  From enrollment to the end of treatment at Day 7

• Number of Patients Needing to Switch/Change Their Treatment Regimen

  From enrollment to the end of treatment at Day 7

• Number of Participants With Failure of Treatment (Need for Mechanical Ventilation or Death)

  From enrollment to the end of treatment at Day 7

Study Arms (2)

Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)

EXPERIMENTAL

Revefenacin 175 μg once per day and Formoterol 20 μg twice per day via jet nebulizer for 7 days or until discharge if prior to day 7.

Drug: Revefenacin (YUPELRI) & Formoterol (Perforomist)

Group 2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin) as Standard of Care

ACTIVE COMPARATOR

Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.

Drug: Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)

Interventions

Revefenacin (YUPELRI) & Formoterol (Perforomist) DRUG

Revefenacin is a Long-acting anticholinergics (LAMAs) and Formoterol is Long-acting bronchodilators, beta-agonists (LABAs).

Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)

Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic) DRUG

Albuterol Inhalation Aerosol (short-acting beta-agonists) \& Ipratropium Aerosol (short-acting anticholinergic)

Group 2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin) as Standard of Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• Any Race
• ≥ 40 years of age
• Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD
• Able to understand and comply with study procedures
• Willingness to sign and date an Informed Consent Form

You may not qualify if:

• 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, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support
• Patients who, per the investigator, have unstable cardiovascular disease (e.g., uncontrolled, hypertension, unstable angina, recent MI (within 12 weeks), ventricular arrhythmia, or decompensated heart failure)
• Patients with a current diagnosis of lung cancer requiring treatment
• Patients that test positive for COVID-19
• Pulmonary diseases other than COPD, or lobar pneumonia
• Patients with acute psychiatric illness deemed significant by the investigator
• Patients with a history of glaucoma deemed significant by the investigator
• History of urinary retention deemed significant by the investigator
• Women who are pregnant or breast feeding

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead
• Mylan Pharmaceuticals Inc: collaborator

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920-6999, United States

Location

Related Publications (1)

• Dhand R, Treat S, Ferris J, Terry PD, Walker T, Elder S, Church D, Dennis D, Faircloth B, Onar G, Heidel RE, Biney I, Valdes M, Bhagat M, Fuerst N, Cusick S. Safety, Efficacy, and Feasibility of Nebulized Long-Acting Bronchodilators vs Short-Acting Bronchodilators in Hospitalized Patients With Acute Exacerbations of COPD: A Phase IV, Randomized, Parallel-Group Clinical Trial. CHEST Pulmonary. 2024 Dec;2(4):100105

  RESULT

Related Links

• Results Publication Link

MeSH Terms

Interventions

revefenacin; Formoterol Fumarate

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Rajiv Dhand, MD
• Organization: University of Tennessee Graduate School of Medicine, Professor and Chair Department of Medicine; Division of Pulmonary Medicine Section of Critical Care Medicine,

rdhand@utmck.edu

+1-865-305-9340

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participating patients with AECOPD will be randomized 1:1 to either a standard bronchodilator protocol with nebulized Albuterol and Ipratropium every 6 hours or nebulized Revefenacin 175 μg once per day and Formoterol 20 μg twice per day. Each patient will have a single randomization number indicating the allocated treatment. The treatment assignments will be generated with the use of a pseudo-random-number generator with stratification for age groups (\<50, 50-69, \>70) that will be used to ensure balance of these factors in the numbers of subjects assigned to each of the two treatments. The allocation to treatment arms will be according to a predetermined computer-generated randomization schedule that will not be disclosed to the clinical investigators.

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: December 7, 2020
• Study Start: December 9, 2020
• Primary Completion: January 19, 2023
• Study Completion: June 1, 2023
• Last Updated: August 3, 2026
• Results First Posted: August 3, 2026

Record last verified: 2026-07

Locations

US (1)