COPD Exacerbation
Conditions
Keywords
ECOPD
Brief summary
The primary aim is to determine whether nebulized Formoterol twice daily plus Revefenacin once daily is non-inferior to standard-of-care nebulized Albuterol and Ipratropium therapy four times daily in relieving dyspnea among patients with ECOPD presenting to the ED and requiring hospitalization, as measured by the Modified Borg Dyspnea Scale. The hypothesize is that patients in the ED for ECOPD, improvement in symptoms, safety, and length of ED or hospital stay after treatment with nebulized Revefenacin and Formoterol will be non-inferior to the Albuterol and Ipratropium combination. The long-acting bronchodilator regimen will provide comparable symptom control with fewer total drug doses compared with standard treatment with short-acting bronchodilators, namely, nebulized Albuterol and Ipratropium. To the best of our knowledge, this will be the first prospective, randomized, double-blind investigation to compare a combination of long-acting nebulized LAMA/LABA bronchodilators with a standard-of-care combination of short-acting nebulized SAMA/SABA bronchodilators in patients with an ECOPD in the ED/hospital setting.
Interventions
DRUGRevefenacin
Revefenacin 175 µg in 3 mL inhalation solution administered once daily in the morning via oral inhalation using a jet nebulizer.
DRUGformoterol fumarate
Formoterol fumarate 20 μg in 2 mL inhalation solution administered twice daily in the morning and evening via oral inhalation using a jet nebulizer.
Twice daily (sterile normal saline 3 ml) to maintain blinding and mask the difference in dosing frequency compared with the comparator arm.
Albuterol sulfate 2.5 mg in 3 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.
DRUGIpratropium Bromide
Ipratropium Bromide 500 μg in 2.5 mL inhalation solution administered 4 times daily via oral inhalation using a jet nebulizer.
Sponsors
University of Tennessee Graduate School of Medicine
Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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. History of COPD based on EMR or confirmed verbally by the patient 5. Presenting to the ED with a primary diagnosis of ECOPD or acute respiratory failure with a secondary diagnosis of COPD 6. Able to understand and comply with study procedures 7. 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 who have previously participated in the study 5. Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support based on: i. Inability to maintain respiratory effort ii. Cyanosis iii. Hemodynamic instability iv. Deterioration in mental status 6. 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) 7. Patients with a current diagnosis of lung cancer requiring treatment 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 breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Modified Borg Dyspnea Scale scores between groups | From enrollment through Day 7 (end of treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients discharged home from the ED | From enrollment through Day 7 (end of treatment) | — |
| Number of patients admitted to a hospital floor or require ED observation for >24 hours (in-hospital patients) | From enrollment through Day 7 (end of treatment) | — |
| Length of hospital or ED stay | From enrollment through Day 7 (end of treatment) | — |
| Number of Participants with the Need to Switch Therapy | From enrollment through Day 7 (end of treatment) | — |
| Total number of bronchodilator doses per hospital or ED stay | From enrollment through Day 7 (end of treatment) | — |
| Total number of rescue doses used | From enrollment through Day 7 (end of treatment) | — |
| Number of Participants with Failure of Treatment (Need for Mechanical Ventilation or Death | From enrollment through Day 7 (end of treatment) | Failure of treatment will be defined as any of the following: death, the need for a patient to receive mechanical ventilation, or the need for a patient to discontinue long-acting bronchodilators during the trial. The need for rescue medications while maintaining the assigned treatment will not be considered a failure of treatment. |
| Number of Participants Requiring Supplemental Oxygen | From enrollment through Day 7 (end of treatment) | — |
| Differences in FEV1/FVC values between enrollment and discharge/end of study. | From enrollment through Day 7 (end of treatment) | Bedside spirometry will be performed by respiratory therapists with the patient in a sitting position using a handheld portable spirometer. The patient will be asked to make a tight seal around the mouthpiece with their lips and forcefully exhale after a deep inhalation. The patient will be instructed to continue forceful and rapid exhalation until no more air is expelled from their lungs. The best of 3 efforts will be used for analysis. FEV1/FVC\<0.7 will be used to diagnose airflow obstruction. |
Countries
United States
Outcome results
None listed