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

Last updated: November 13, 2022
Sponsor: University of Tennessee Graduate School of Medicine
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04655170
UTGSM 4586
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or Female
  2. Any Race
  3. ≥ 40 years of age
  4. Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratoryfailure with a secondary diagnosis of COPD
  5. Able to understand and comply with study procedures
  6. Willingness to sign and date an Informed Consent Form

Exclusion

Exclusion Criteria:

  1. Patients unable or unwilling to sign an informed consent or cooperate with studyprocedures
  2. Patients who are hypersensitive to Formoterol or Revefenacin
  3. Patients who are intubated, have tracheotomy, are receiving mechanical ventilation bymask or artificial airway
  4. Patients, in the opinion of the investigators, who are rapidly decompensating and areimmediately in need, or will soon need, ventilator support
  5. Patients who, per the investigator, have unstable cardiovascular disease (e.g.,uncontrolled, hypertension, unstable angina, recent MI (within 12 weeks), ventriculararrhythmia, or decompensated heart failure)
  6. Patients with a current diagnosis of lung cancer requiring treatment
  7. Patients that test positive for COVID-19
  8. Pulmonary diseases other than COPD, or lobar pneumonia
  9. Patients with acute psychiatric illness deemed significant by the investigator
  10. Patients with a history of glaucoma deemed significant by the investigator
  11. History of urinary retention deemed significant by the investigator

12 Women who are pregnant or breast feeding

Study Design

Total Participants: 60
Study Start date:
December 09, 2020
Estimated Completion Date:
March 30, 2023

Study Description

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).

Connect with a study center

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920-6999
    United States

    Active - Recruiting

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