Trial Outcomes & Findings for Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD (NCT NCT04655170)
NCT ID: NCT04655170
Last Updated: 2026-08-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
From enrollment to the end of treatment at Day 7
Results posted on
2026-08-03
Participant Flow
Participant milestones
| Measure |
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
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
|
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
Baseline characteristics by cohort
| Measure |
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
n=30 Participants
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
|
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
n=30 Participants
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 9.51 • n=20 Participants
|
64.5 years
STANDARD_DEVIATION 9.05 • n=20 Participants
|
63.2 years
STANDARD_DEVIATION 9.30 • n=40 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
54 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Non-White Hispanic/Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Smoking status
Active tobacco use
|
20 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
39 Participants
n=40 Participants
|
|
Smoking status
Previous tobacco use
|
10 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Smoking status
Does not smoke
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
CCI Score
|
4.7 Scores on a scale
STANDARD_DEVIATION 2.59 • n=20 Participants
|
4.7 Scores on a scale
STANDARD_DEVIATION 2.20 • n=20 Participants
|
4.7 Scores on a scale
STANDARD_DEVIATION 2.38 • n=40 Participants
|
|
CCI estimated 10-y survival %
|
43.9 Percentage
STANDARD_DEVIATION 37.16 • n=20 Participants
|
40.8 Percentage
STANDARD_DEVIATION 35.14 • n=20 Participants
|
42.3 Percentage
STANDARD_DEVIATION 35.89 • n=40 Participants
|
|
Comorbidity according to CCI score
No comorbidity (score ≤ 1)
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Comorbidity according to CCI score
Mild comorbidity (score2)
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Comorbidity according to CCI score
High comorbidity (score ≥ 3)
|
24 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
49 Participants
n=40 Participants
|
|
No. of comorbid diseases
At least 3 diseases
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
No. of comorbid diseases
4-7 diseases
|
13 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
No. of comorbid diseases
8-11 diseases
|
5 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
No. of comorbid diseases
≥ 12 diseases
|
9 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From enrollment to the end of treatment at Day 7Population: The reported values are marginal means derived from a repeated-measures statistical model using all available assessments collected during the treatment period.
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.
Outcome measures
| Measure |
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
n=30 Participants
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
|
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
n=30 Participants
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
|
|---|---|---|
|
Difference in Modified Borg Dyspnea Scale Scores Between Groups
|
1.89 scores on a scale
Interval 1.34 to 2.45
|
1.92 scores on a scale
Interval 1.37 to 2.46
|
SECONDARY outcome
Timeframe: From enrollment to the end of treatment at Day 7Population: Total Respiratory Therapy Visits for Study Drug Administration Per Day Among Patients Hospitalized for Exacerbations of COPD. Alb/Ipr = patients received nebulized albuterol 2.5 mg and ipratropium 500 mg every 6 h (4 times per day) over the 7-d treatment period; For/Rev = patients received nebulized formoterol 20 mg every 12 h and revefenacin 175 mg every 24 h over the 7-d treatment period
Outcome measures
| Measure |
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
n=30 Participants
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
|
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
n=30 Participants
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
|
|---|---|---|
|
Total Visits for Study Drug Administration Per Day Received by Each Patient
Day 1
|
1.50 visits
Interval 1.0 to 2.0
|
2.00 visits
Interval 1.5 to 2.5
|
|
Total Visits for Study Drug Administration Per Day Received by Each Patient
Day 2
|
2.00 visits
Interval 2.0 to 2.0
|
4.00 visits
Interval 3.0 to 5.0
|
|
Total Visits for Study Drug Administration Per Day Received by Each Patient
Day 3
|
2.00 visits
Interval 1.5 to 2.5
|
3.00 visits
Interval 2.0 to 4.0
|
|
Total Visits for Study Drug Administration Per Day Received by Each Patient
Day 4
|
2.00 visits
Interval 1.5 to 2.5
|
3.50 visits
Interval 2.0 to 5.0
|
|
Total Visits for Study Drug Administration Per Day Received by Each Patient
Day 5
|
2.00 visits
Interval 2.0 to 2.0
|
4.00 visits
Interval 3.5 to 4.5
|
|
Total Visits for Study Drug Administration Per Day Received by Each Patient
Day 6
|
2.00 visits
Interval 1.625 to 2.375
|
4.00 visits
Interval 2.75 to 5.25
|
|
Total Visits for Study Drug Administration Per Day Received by Each Patient
Day 7
|
2.00 visits
Interval 2.0 to 2.0
|
4.00 visits
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: From enrollment to the end of treatment at Day 7Population: The reported values are marginal means derived from a repeated-measures statistical model using all available assessments collected during the treatment period.
Outcome measures
| Measure |
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
n=30 Participants
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
|
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
n=30 Participants
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
|
|---|---|---|
|
Total Doses of Bronchodilators Per Hospital Stay
|
11.14 doses
Interval 9.34 to 12.94
|
21.96 doses
Interval 16.03 to 27.89
|
SECONDARY outcome
Timeframe: From enrollment to the end of treatment at Day 7Population: The reported values are marginal means derived from a repeated-measures statistical model using all available assessments collected during the treatment period.
Outcome measures
| Measure |
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
n=30 Participants
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
|
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
n=30 Participants
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
|
|---|---|---|
|
Total Number of Rescue Doses Administered During the Hospital Stay in Patients With Exacerbations of COPD
|
1.25 Dose
Interval 0.47 to 2.04
|
0.43 Dose
Interval -0.07 to 0.92
|
SECONDARY outcome
Timeframe: From enrollment to the end of treatment at Day 7Outcome measures
| Measure |
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
n=30 Participants
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
|
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
n=30 Participants
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
|
|---|---|---|
|
Number of Patients Needing to Switch/Change Their Treatment Regimen
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From enrollment to the end of treatment at Day 7Outcome measures
| Measure |
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
n=30 Participants
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
|
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
n=30 Participants
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
|
|---|---|---|
|
Number of Participants With Failure of Treatment (Need for Mechanical Ventilation or Death)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1 and 3Outcome measures
| Measure |
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
n=30 Participants
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
|
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
n=30 Participants
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
|
|---|---|---|
|
Need for Supplemental Oxygen by Nasal Cannula (L/Min) Among Patients With Exacerbations of COPD
Day 1
|
2.15 L/min
Standard Deviation 1.78 • Interval 1.43 to 2.49
|
2.20 L/min
Standard Deviation 1.69 • Interval 0.74 to 6.37
|
|
Need for Supplemental Oxygen by Nasal Cannula (L/Min) Among Patients With Exacerbations of COPD
Day 3
|
1.66 L/min
Standard Deviation 1.45
|
1.82 L/min
Standard Deviation 1.28
|
Adverse Events
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
n=30 participants at risk
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
|
Active Comparator: Group 2: Ipratropium Bromide (Atrovent) & Albuterol(Ventolin) as Standard of Care
n=30 participants at risk
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oxygen desaturation
|
0.00%
0/30 • From enrollment to the end of treatment at Day 7
|
3.3%
1/30 • Number of events 1 • From enrollment to the end of treatment at Day 7
|
Additional Information
Rajiv Dhand, MD
University of Tennessee Graduate School of Medicine, Professor and Chair Department of Medicine; Division of Pulmonary Medicine Section of Critical Care Medicine,
Phone: +1-865-305-9340
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place