Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mylan Pharmaceuticals Inc | INDUSTRY |
Not provided
Not provided
Not provided
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:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist) | Experimental | Revefenacin 175 μg once per day and Formoterol 20 μg twice per day via jet nebulizer for 7 days or until discharge if prior to day 7. |
|
| Group 2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin) as Standard of Care | Active Comparator | Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revefenacin (YUPELRI) & Formoterol (Perforomist) | Drug | Revefenacin is a Long-acting anticholinergics (LAMAs) and Formoterol is Long-acting bronchodilators, beta-agonists (LABAs). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | up to 7 days |
| The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
12 Women who are pregnant or breast feeding
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Ferris, MSHS | Contact | 865-305-7975 | jferris@utmck.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Medical Center | Recruiting | Knoxville | Tennessee | 37920-6999 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic) | Drug | Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic) |
|
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.
| 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. | 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. | 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. | 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. | Through study completion, up to 7 days |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 10, 2026 | Jul 7, 2026 | 3 |
| ID | Term |
|---|---|
| C583570 | revefenacin |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
Not provided
Not provided