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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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)
University of Tennessee Medical Center
Knoxville, Tennessee, United States
RECRUITINGDifference in Borg Dyspnea Scale scores between groups
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.
Time frame: change from baseline borg dyspnea score at day 3
Difference in Borg Dyspnea Scale scores between groups
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.
Time frame: change from baseline borg dyspnea score at day 7
Difference in Borg Dyspnea Scale scores between groups
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.
Time frame: change from day 3 borg dyspnea score at day 7
Difference in the mean total doses of short acting bronchodilators (rescue) used during study participation between each group.
Subject in both groups will be allowed to use standard of care rescue short-acting bronchodilators throughout their study participation.
Time frame: up to 7 days
The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2
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.
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Time frame: at baseline
The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2
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.
Time frame: at day 3
The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2
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.
Time frame: at day 7
Number of total subjects that had to stop treatment early between groups
Total percent of patients that had to switch therapy due to lack of response between each group.
Time frame: Through study completion, up to 7 days
The total number of subjects with Adverse Events, SAE's, ET, and Deaths between groups.
Adverse Events, SAE's, ET, and Deaths will be recorder for every subjects in both groups until the end of their study participation.
Time frame: Through study completion, up to 7 days