COPD ExacerbationPhase 4NCT04655170
Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
A Phase 4 study testing Revefenacin (YUPELRI) & Formoterol (Perforomist) and Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic) in people with COPD Exacerbation, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Revefenacin (YUPELRI) & Formoterol (Perforomist) and Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 1 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- Any Race
- ≥ 40 years of age
- Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD
- Able to understand and comply with study procedures
- Willingness to sign and date an Informed Consent Form
Who cannot join
- Patients unable or unwilling to sign an informed consent or cooperate with study procedures
- Patients who are hypersensitive to Formoterol or Revefenacin
- Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway
- Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support
- 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)
- Patients with a current diagnosis of lung cancer requiring treatment
Show all 12Show fewer
- Patients that test positive for COVID-19
- Pulmonary diseases other than COPD, or lobar pneumonia
- Patients with acute psychiatric illness deemed significant by the investigator
- Patients with a history of glaucoma deemed significant by the investigator
- History of urinary retention deemed significant by the investigator
- 12 Women who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Center
Knoxville, Tennessee, 37920-6999
About this study
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
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.
Read the 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).
- Conditions
- COPD Exacerbation
- Being tested
- Revefenacin (YUPELRI) & Formoterol (Perforomist), Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revefenacin (YUPELRI) & Formoterol (Perforomist)Drug
Revefenacin is a Long-acting anticholinergics (LAMAs) and Formoterol is Long-acting bronchodilators, beta-agonists (LABAs).
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Revefenacin (YUPELRI) & Formoterol (Perforomist) |
| 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. Receives: Drug: Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Modified Borg Dyspnea Scale Scores Between Groups
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.
Measured: From enrollment to the end of treatment at Day 7
Secondary outcomes (6)
Total Visits for Study Drug Administration Per Day Received by Each Patient
Measured: From enrollment to the end of treatment at Day 7
Total Doses of Bronchodilators Per Hospital Stay
Measured: 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
Measured: From enrollment to the end of treatment at Day 7
Number of Patients Needing to Switch/Change Their Treatment Regimen
Measured: From enrollment to the end of treatment at Day 7
Number of Participants With Failure of Treatment (Need for Mechanical Ventilation or Death)
Measured: 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
Measured: Days 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start9 Dec 2020
- Primary completion19 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Mylan Pharmaceuticals Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655170
- Sponsor's protocol ID
- UTGSM 4586
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2020
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dhand R, Treat S, Ferris J, Terry PD, Walker T, Elder S, Church D, Dennis D, Faircloth B, Onar G, Heidel RE, Biney I, Valdes M, Bhagat M, Fuerst N, Cusick S. Safety, Efficacy, and Feasibility of Nebulized Long-Acting Bronchodilators vs Short-Acting Bronchodilators in Hospitalized Patients With Acute Exacerbations of COPD: A Phase IV, Randomized, Parallel-Group Clinical Trial. CHEST Pulm. 2024 Sep 11;2(4):100105. doi: 10.1016/j.chpulm.2024.100105. eCollection 2024 Dec.
PubMed 42548489
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04655170
- Acronym / sponsor ID
- UTGSM 4586
- Conditions
- COPD Exacerbation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Mylan Pharmaceuticals Inc
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 3 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist) | Experimental | Drug: 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. |
| Group 2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin) as Standard of Care | Active comparator | Drug: Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female
- Any Race
- ≥ 40 years of age
- Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD
- Able to understand and comply with study procedures
Key exclusion criteria (12 listed)
- Patients unable or unwilling to sign an informed consent or cooperate with study procedures
- Patients who are hypersensitive to Formoterol or Revefenacin
- Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway
- Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revefenacin (YUPELRI) & Formoterol (Perforomist)Revefenacin is a Long-acting anticholinergics (LAMAs) and Formoterol is Long-acting bronchodilators, beta-agonists (LABAs). | Drug | Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist) |
| Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)Albuterol Inhalation Aerosol (short-acting beta-agonists) \& Ipratropium Aerosol (short-acting anticholinergic) | Drug | Group 2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin) as Standard of Care |
Primary outcome
Difference in Modified Borg Dyspnea Scale Scores Between Groups
Time frame: 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.
6 secondary outcomes
Total Visits for Study Drug Administration Per Day Received by Each Patient
Time frame: From enrollment to the end of treatment at Day 7
Total Doses of Bronchodilators Per Hospital Stay
Time frame: 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
Time frame: From enrollment to the end of treatment at Day 7
Number of Patients Needing to Switch/Change Their Treatment Regimen
Time frame: From enrollment to the end of treatment at Day 7
Number of Participants With Failure of Treatment (Need for Mechanical Ventilation or Death)
Time frame: 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
Time frame: Days 1 and 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 42548489Dhand R, Treat S, Ferris J, Terry PD, Walker T, Elder S, Church D, Dennis D, Faircloth B, Onar G, Heidel RE, Biney I, Valdes M, Bhagat M, Fuerst N, Cusick S. Safety, Efficacy, and Feasibility of Nebulized Long-Acting Bronchodilators vs Short-Acting Bronchodilators in Hospitalized Patients With Acute Exacerbations of COPD: A Phase IV, Randomized, Parallel-Group Clinical Trial. CHEST Pulm. 2024 Sep 11;2(4):100105. doi: 10.1016/j.chpulm.2024.100105. eCollection 2024 Dec.
- Results Publication LinkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Revefenacin (YUPELRI) & Formoterol (Perforomist) and Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic) in people with COPD Exacerbation, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Modified Borg Dyspnea Scale Scores Between Groups (time frame: From enrollment to the end of treatment at Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04655170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.