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 | Unknown Phase 4 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 (9)

• Difference in 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.

  change from baseline borg dyspnea score at day 3

• Difference in 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.

  change from baseline borg dyspnea score at day 7

• Difference in 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.

  change from day 3 borg dyspnea score at day 7

• Difference in the mean total doses of short acting bronchodilators (rescue) used during study participation between each group.

  Subject in both groups will be allowed to use standard of care rescue short-acting bronchodilators throughout their study participation.

  up to 7 days

• The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2

  The lowest level of FiO2 will be recorded from the subjects EMR record at each visit during study participation and the difference between group 1 and group 2 will be noted.

  at baseline

• The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2

  The lowest level of FiO2 will be recorded from the subjects EMR record at each visit during study participation and the difference between group 1 and group 2 will be noted.

  at day 3

• The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2

  The lowest level of FiO2 will be recorded from the subjects EMR record at each visit during study participation and the difference between group 1 and group 2 will be noted.

  at day 7

• Number of total subjects that had to stop treatment early between groups

  Total percent of patients that had to switch therapy due to lack of response between each group.

  Through study completion, up to 7 days

• The total number of subjects with Adverse Events, SAE's, ET, and Deaths between groups.

  Adverse Events, SAE's, ET, and Deaths will be recorder for every subjects in both groups until the end of their study participation.

  Through study completion, up to 7 days

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

RECRUITING

MeSH Terms

Interventions

revefenacin; Formoterol Fumarate

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Central Study Contacts

Jennifer Ferris, MSHS

CONTACT

865-305-7975; jferris@utmck.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Department of Medicine; Division of Pulmonary Medicine Section of Critical Care Medicine

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 30, 2023
• Study Completion: March 30, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

US (1)