Overview

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
Trial end date:
2022-04-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Tennessee Graduate School of Medicine
Collaborator:
Mylan Pharmaceuticals
Treatments:
Albuterol
Cholinergic Antagonists
Formoterol Fumarate
Ipratropium
Criteria
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 respiratory
failure 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 Criteria:

1. Patients unable or unwilling to sign an informed consent or cooperate with study
procedures

2. Patients who are hypersensitive to Formoterol or Revefenacin

3. Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by
mask or artificial airway

4. Patients, in the opinion of the investigators, who are rapidly decompensating and are
immediately 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), ventricular
arrhythmia, 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