COPD Exacerbation
Conditions
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).
Interventions
DRUGRevefenacin (YUPELRI) & Formoterol (Perforomist)
Revefenacin is a Long-acting anticholinergics (LAMAs) and Formoterol is Long-acting bronchodilators, beta-agonists (LABAs).
DRUGAlbuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)
Albuterol Inhalation Aerosol (short-acting beta-agonists) \& Ipratropium Aerosol (short-acting anticholinergic)
Sponsors
University of Tennessee Graduate School of Medicine
Mylan Pharmaceuticals Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Modified Borg Dyspnea Scale Scores Between Groups | From enrollment to the end of treatment at Day 7 | The Modified Borg Dyspnea 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 scale was recorded prior to dosing twice a day between 7 and 9 am \& pm. |
Secondary
| Measure | Time frame |
|---|---|
| Total Visits for Study Drug Administration Per Day Received by Each Patient | From enrollment to the end of treatment at Day 7 |
| Total Doses of Bronchodilators Per Hospital Stay | From enrollment to the end of treatment at Day 7 |
| Total Number of Rescue Doses Administered During the Hospital Stay in Patients With Exacerbations of COPD | From enrollment to the end of treatment at Day 7 |
| Number of Patients Needing to Switch/Change Their Treatment Regimen | From enrollment to the end of treatment at Day 7 |
| Number of Participants With Failure of Treatment (Need for Mechanical Ventilation or Death) | From enrollment to the end of treatment at Day 7 |
| Need for Supplemental Oxygen by Nasal Cannula (L/Min) Among Patients With Exacerbations of COPD | Days 1 and 3 |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 9.51 |
| CCI estimated 10-y survival % | 40.8 Percentage STANDARD_DEVIATION 35.14 |
| CCI Score | 4.7 Scores on a scale STANDARD_DEVIATION 2.2 |
| Comorbidity according to CCI score High comorbidity (score ≥ 3) | 25 Participants |
| Comorbidity according to CCI score Mild comorbidity (score2) | 3 Participants |
| Comorbidity according to CCI score No comorbidity (score ≤ 1) | 0 Participants |
| No. of comorbid diseases ≥ 12 diseases | 11 Participants |
| No. of comorbid diseases 4-7 diseases | 18 Participants |
| No. of comorbid diseases 8-11 diseases | 5 Participants |
| No. of comorbid diseases At least 3 diseases | 3 Participants |
| Race/Ethnicity, Customized Black | 2 Participants |
| Race/Ethnicity, Customized Non-White Hispanic/Asian | 0 Participants |
| Race/Ethnicity, Customized White | 28 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 17 Participants |
| Smoking status Active tobacco use | 19 Participants |
| Smoking status Does not smoke | 2 Participants |
| Smoking status Previous tobacco use | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
None listed