Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04655170

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

COPD Exacerbation

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920-6999, United States

Location status: Recruiting

Location contact

Jennifer Ferris, MSHS

CONTACT

[email protected]

865-305-7975

About this study

A prospective, parallel group, randomized clinical trial in 60 patients hospitalized with the primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD (ICD-10 codes J44.1 and J96 - J96.2 with J44.9).

The plan is to:

Administer standard bronchodilator protocol with nebulized Albuterol and Ipratropium every 6 hours (n=30)

versus

Nebulized Revefenacin 175 μg once per day and Formoterol 20 μg twice per day (n=30) for up to 7 days of treatment. Study medication will be administered by standard jet nebulizers in both groups.

Investigators will:

  • Collect the Borg dyspnea scale twice a day during hospitalization
  • Record the total doses of bronchodilators per day received by each patient
  • Record the number of rescue doses needed per day of hospital stay
  • Record the lowest level of FiO2 employed on days 1, 3 and 7 of hospital stay
  • Record all adverse events and concurrent medications

Investigators will collect:

Physical Exam (Day 1, 3, 7, or ET) Serum Chemistry (Day 1, 3, 7, or ET) Hematology (Day 1, 3, 7, or ET) Chest X-Ray (Day 1).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

12 Women who are pregnant or breast feeding

Treatment and study plan

Revefenacin (YUPELRI) & Formoterol (Perforomist)

Drug

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

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)

Primary outcomes

  1. Difference in Borg Dyspnea Scale scores between groups

    Time frame: change from baseline borg dyspnea score at day 3

    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.

  2. Difference in Borg Dyspnea Scale scores between groups

    Time frame: change from baseline borg dyspnea score at day 7

    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.

  3. Difference in Borg Dyspnea Scale scores between groups

    Time frame: change from day 3 borg dyspnea score at day 7

    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.

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

    Time frame: up to 7 days

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

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

    Time frame: at baseline

    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.

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

    Time frame: at day 3

    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.

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

    Time frame: at day 7

    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.

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

    Time frame: Through study completion, up to 7 days

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

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

    Time frame: Through study completion, up to 7 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Ferris, MSHS

CONTACT

[email protected]

865-305-7975

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Collaborators

  • Mylan Pharmaceuticals Inc

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2020
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.