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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2022
  • participants needed
    60
  • sponsor
    University of Tennessee Graduate School of Medicine
Updated on 9 May 2021

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.

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 g once per day and Formoterol 20 g 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).

Details
Condition COPD Exacerbation
Treatment Revefenacin (YUPELRI) & Formoterol (Perforomist), Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)
Clinical Study IdentifierNCT04655170
SponsorUniversity of Tennessee Graduate School of Medicine
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

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
Women who are pregnant or breast feeding
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