Clinical trial NCT04655170: Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
Official title: Randomized, Parallel-group Trial to Evaluate Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COPD Exacerbation
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: Mylan Pharmaceuticals Inc
First posted: 2020-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participating patients with AECOPD will be randomized 1:1 to either a standard bronchodilator protocol with nebulized Albuterol and Ipratropium every 6 hours or nebulized Revefenacin 175 μg once per day and Formoterol 20 μg twice per day. Each patient will have a single randomization number indicating the allocated treatment. The treatment assignments will be generated with the use of a pseudo-random-number generator with stratification for age groups (\<50, 50-69, \>70) that will be used to ensure balance of these factors in the numbers of subjects assigned to each of the two treatments. The allocation to

treatment arms will be according to a predetermined computer-generated randomization schedule that will not be disclosed to the clinical investigators.
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Difference in Borg Dyspnea Scale scores between groups
timeFrame: change from baseline borg dyspnea score at day 3
measure: Difference in Borg Dyspnea Scale scores between groups
timeFrame: change from baseline borg dyspnea score at day 7
measure: Difference in Borg Dyspnea Scale scores between groups
timeFrame: change from day 3 borg dyspnea score at day 7
measure: Difference in the mean total doses of short acting bronchodilators (rescue) used during study participation between each group.
timeFrame: up to 7 days
measure: The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2
timeFrame: at baseline
measure: The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2
timeFrame: at day 3
measure: The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2
timeFrame: at day 7
measure: Number of total subjects that had to stop treatment early between groups
timeFrame: Through study completion, up to 7 days
measure: The total number of subjects with Adverse Events, SAE's, ET, and Deaths between groups.
timeFrame: Through study completion, up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
References: