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

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).

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